Trial Outcomes & Findings for Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study) (NCT NCT05648110)
NCT ID: NCT05648110
Last Updated: 2026-06-18
Results Overview
Primary: (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected through Day 451
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
3882 participants
Primary outcome timeframe
AEs: through 90 days post each IMP administration; SAEs, MAAEs, and AESIs: through Day 451
Results posted on
2026-06-18
Participant Flow
In Main Cohort, 3348 participants 12 years of age or older were randomized 1:1 to receive AZD3152 or comparator. In Sentinel Cohort, 57 participants were randomized 5:2 to receive AZD5156 (41 participants) or Placebo (16 participants). In Sub-study, 476 participants, 18 years of age or older, were randomized 2:1 to receive AZD3152 or AZD7442.
Overall 3713 participants were screened in the Main Study; 87 screened for the Sentinel Cohort; 576 participants were screened in the Sub-study.
Participant milestones
| Measure |
Placebo, Anterolateral Thigh - Sentinel Cohort
(Planned treatment is placebo 600 mg IM in anterolateral thigh area)
|
AZD3152 - Sub Study
Planned treatment assignment is ADZ3152 1200mg IV at Day 1.
|
AZD7442 - Sub Study
Planned treatment is AZD7442 300mg IM at Day 1.
|
AZD3152 - Main Cohort
Planned treatment assignments are AZD3152 300mg IM at Day 1 and AZD3152 300mg IM at Day 181.
|
AZD7442 - Main Cohort
Planned treatment assignments are AZD7442 600mg IM on Day 1 and placebo on Day 181.
|
Placebo - Main Cohort
Planned treatment assignments are placebo on Day 1 and placebo on Day 181.
|
AZD5156, Gluteal - Sentinel Cohort
(Planned treatment assignment is AZD5156 600 mg IM in gluteal area)
|
AZD5156, Anterolateral Thigh - Sentinel Cohort
(Planned treatment assignment is AZD5156 600 mg IM in anterolateral thigh area)
|
Placebo, Gluteal - Sentinel Cohort
(Planned treatment assignment is placebo 600 mg in gluteal area)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
310
|
158
|
1671
|
1102
|
561
|
20
|
21
|
8
|
|
Overall Study
COMPLETED
|
6
|
277
|
142
|
1469
|
962
|
513
|
19
|
18
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
33
|
16
|
202
|
140
|
48
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo, Anterolateral Thigh - Sentinel Cohort
(Planned treatment is placebo 600 mg IM in anterolateral thigh area)
|
AZD3152 - Sub Study
Planned treatment assignment is ADZ3152 1200mg IV at Day 1.
|
AZD7442 - Sub Study
Planned treatment is AZD7442 300mg IM at Day 1.
|
AZD3152 - Main Cohort
Planned treatment assignments are AZD3152 300mg IM at Day 1 and AZD3152 300mg IM at Day 181.
|
AZD7442 - Main Cohort
Planned treatment assignments are AZD7442 600mg IM on Day 1 and placebo on Day 181.
|
Placebo - Main Cohort
Planned treatment assignments are placebo on Day 1 and placebo on Day 181.
|
AZD5156, Gluteal - Sentinel Cohort
(Planned treatment assignment is AZD5156 600 mg IM in gluteal area)
|
AZD5156, Anterolateral Thigh - Sentinel Cohort
(Planned treatment assignment is AZD5156 600 mg IM in anterolateral thigh area)
|
Placebo, Gluteal - Sentinel Cohort
(Planned treatment assignment is placebo 600 mg in gluteal area)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
2
|
0
|
40
|
24
|
6
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
15
|
7
|
47
|
29
|
14
|
0
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
3
|
18
|
15
|
3
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
14
|
3
|
90
|
71
|
23
|
0
|
0
|
0
|
|
Overall Study
Missing reason
|
0
|
1
|
2
|
4
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
Baseline characteristics by cohort
| Measure |
AZD3152 - Main Cohort
n=1671 Participants
(AZD3152 Experimental treatment)
|
AZD7442 - Main Cohort
n=1102 Participants
(AZD7442 Active Comparator treatment)
|
Placebo - Main Cohort
n=561 Participants
(Placebo comparator treatment)
|
AZD5156 - Sentinel Cohort
n=41 Participants
(AZD5156 Experimental treatment)
|
Placebo - Sentinel Cohort
n=16 Participants
(Placebo comparator treatment)
|
AZD3152 - Sub Study
n=310 Participants
(AZD3152 Experimental treatment)
|
AZD7442 - Sub Study
n=158 Participants
(AZD7442 Active Comparator treatment)
|
Total
n=3859 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 13.9 • n=20 Participants
|
58.6 years
STANDARD_DEVIATION 13.7 • n=20 Participants
|
57.7 years
STANDARD_DEVIATION 13.2 • n=40 Participants
|
35.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
32.3 years
STANDARD_DEVIATION 9.5 • n=9 Participants
|
48.9 years
STANDARD_DEVIATION 15.8 • n=6 Participants
|
48.6 years
STANDARD_DEVIATION 16.9 • n=6 Participants
|
56.7 years
STANDARD_DEVIATION 14.6 • n=6 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
8 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
|
Age, Customized
Adults (18-64 years)
|
1057 Participants
n=20 Participants
|
678 Participants
n=20 Participants
|
375 Participants
n=40 Participants
|
41 Participants
n=5 Participants
|
16 Participants
n=9 Participants
|
250 Participants
n=6 Participants
|
126 Participants
n=6 Participants
|
2543 Participants
n=6 Participants
|
|
Age, Customized
From 65-84 years
|
597 Participants
n=20 Participants
|
403 Participants
n=20 Participants
|
181 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
60 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
1272 Participants
n=6 Participants
|
|
Age, Customized
85 years and over
|
9 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
29 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
954 Participants
n=20 Participants
|
610 Participants
n=20 Participants
|
329 Participants
n=40 Participants
|
23 Participants
n=5 Participants
|
11 Participants
n=9 Participants
|
169 Participants
n=6 Participants
|
94 Participants
n=6 Participants
|
2190 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
717 Participants
n=20 Participants
|
492 Participants
n=20 Participants
|
232 Participants
n=40 Participants
|
18 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
141 Participants
n=6 Participants
|
64 Participants
n=6 Participants
|
1669 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
202 Participants
n=20 Participants
|
122 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
66 Participants
n=6 Participants
|
33 Participants
n=6 Participants
|
516 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
1241 Participants
n=20 Participants
|
814 Participants
n=20 Participants
|
416 Participants
n=40 Participants
|
27 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
233 Participants
n=6 Participants
|
118 Participants
n=6 Participants
|
2858 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
111 Participants
n=20 Participants
|
94 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
228 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
82 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
42 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
78 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
47 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
41 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
97 Participants
n=6 Participants
|
|
Ethnicity
Hispanic or Latino
|
356 Participants
n=20 Participants
|
235 Participants
n=20 Participants
|
125 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
86 Participants
n=6 Participants
|
40 Participants
n=6 Participants
|
844 Participants
n=6 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
1240 Participants
n=20 Participants
|
841 Participants
n=20 Participants
|
386 Participants
n=40 Participants
|
37 Participants
n=5 Participants
|
14 Participants
n=9 Participants
|
222 Participants
n=6 Participants
|
116 Participants
n=6 Participants
|
2856 Participants
n=6 Participants
|
|
Ethnicity
Not reported
|
75 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
50 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
159 Participants
n=6 Participants
|
|
Race
Black or African American
|
202 Participants
n=20 Participants
|
122 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
66 Participants
n=6 Participants
|
33 Participants
n=6 Participants
|
516 Participants
n=6 Participants
|
|
Race
White
|
1241 Participants
n=20 Participants
|
814 Participants
n=20 Participants
|
416 Participants
n=40 Participants
|
27 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
233 Participants
n=6 Participants
|
118 Participants
n=6 Participants
|
2858 Participants
n=6 Participants
|
|
Race
Asian
|
111 Participants
n=20 Participants
|
94 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
228 Participants
n=6 Participants
|
|
Race
Other
|
28 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
82 Participants
n=6 Participants
|
|
Race
Multiple
|
42 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
78 Participants
n=6 Participants
|
|
Race
Not reported
|
38 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
76 Participants
n=6 Participants
|
|
Race
Missing
|
9 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
21 Participants
n=6 Participants
|
|
SARS-CoV-2 vaccination status within 6 months prior to randomization
Yes SARS-CoV-2 vaccination
|
199 Participants
n=20 Participants
|
147 Participants
n=20 Participants
|
50 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
419 Participants
n=6 Participants
|
|
SARS-CoV-2 vaccination status within 6 months prior to randomization
No SARS-CoV-2 vaccination
|
1472 Participants
n=20 Participants
|
955 Participants
n=20 Participants
|
511 Participants
n=40 Participants
|
38 Participants
n=5 Participants
|
14 Participants
n=9 Participants
|
297 Participants
n=6 Participants
|
153 Participants
n=6 Participants
|
3440 Participants
n=6 Participants
|
|
Prior SARS-CoV-2 infection within 6 months prior to randomization
Yes prior SARS-CoV-2 infection
|
66 Participants
n=20 Participants
|
58 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
135 Participants
n=6 Participants
|
|
Prior SARS-CoV-2 infection within 6 months prior to randomization
No prior SARS-CoV-2 infection
|
1605 Participants
n=20 Participants
|
1044 Participants
n=20 Participants
|
554 Participants
n=40 Participants
|
40 Participants
n=5 Participants
|
16 Participants
n=9 Participants
|
308 Participants
n=6 Participants
|
157 Participants
n=6 Participants
|
3724 Participants
n=6 Participants
|
|
EVUSHELD use within 12 months prior to randomization
Yes EVUSHELD use
|
191 Participants
n=20 Participants
|
148 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
378 Participants
n=6 Participants
|
|
EVUSHELD use within 12 months prior to randomization
No EVUSHELD use
|
1480 Participants
n=20 Participants
|
954 Participants
n=20 Participants
|
522 Participants
n=40 Participants
|
41 Participants
n=5 Participants
|
16 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3013 Participants
n=6 Participants
|
|
EVUSHELD use within 12 months prior to randomization
Missing
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
310 Participants
n=6 Participants
|
158 Participants
n=6 Participants
|
468 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: AEs: through 90 days post each IMP administration; SAEs, MAAEs, and AESIs: through Day 451Population: Safety analysis set: all randomized participants who received part or all of the study intervention.
Primary: (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected through Day 451
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1671 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1102 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=561 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
AESIs
|
45 Participants
|
18 Participants
|
9 Participants
|
|
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
AEs
|
846 Participants
|
591 Participants
|
273 Participants
|
|
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
SAEs
|
315 Participants
|
222 Participants
|
90 Participants
|
|
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
MAAEs
|
976 Participants
|
651 Participants
|
297 Participants
|
PRIMARY outcome
Timeframe: through 29 days post IMP administration (AEs); through Day 451 (SAEs, MAAEs, and AESIs)Population: Safety analysis set: all randomized participants who received part or all of the study intervention.
(Sub-study) Occurrence of AEs collected through 29 days after IMP administration. SAEs, MAAEs, and AESIs collected through Day 451 (ie, end of study).
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=310 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=156 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=2 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
AEs
|
81 Participants
|
32 Participants
|
1 Participants
|
|
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
MAAEs
|
89 Participants
|
65 Participants
|
2 Participants
|
|
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
SAEs
|
15 Participants
|
11 Participants
|
1 Participants
|
|
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
AESIs
|
9 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: at Day 29Population: Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing. Participants without valid serum concentration at Day 29 were excluded from this table.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table only shows AZD3152 and AZD7442 concentration at Day 29.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=281 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=141 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
|
137.3 ug/mL
Geometric Coefficient of Variation 0.56
|
18.7 ug/mL
Geometric Coefficient of Variation 0.61
|
—
|
PRIMARY outcome
Timeframe: at Day 29Population: Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing. Participants without valid serum concentration at Day 29 were excluded from this table.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table shows the predicted nAb titer at Day 29 (please see the previous table for AZD3152 and AZD7442 concentration at Day 29).
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=281 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=141 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
|
36127.1 1/Dilution
Geometric Coefficient of Variation 0.56
|
8882.5 1/Dilution
Geometric Coefficient of Variation 0.61
|
—
|
PRIMARY outcome
Timeframe: at Primary Analysis: average follow-up time of 170 daysPopulation: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
(Main Cohort) Confirmed symptomatic COVID-19 case at Primary Analysis.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Confirmed Symptomatic COVID-19 Case
|
122 Participants
|
117 Participants
|
61 Participants
|
PRIMARY outcome
Timeframe: at Primary Analysis: average follow-up time of 170 daysPopulation: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
(Main Cohort) Confirmed symptomatic COVID-19 case attributable to matched variants at Primary Analysis.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Confirmed Symptomatic COVID-19 Case Attributable to Matched Variants
|
54 Participants
|
55 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: through Day 461Population: Safety analysis set: all randomized participants who received part or all of the study intervention.
Primary: (Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs collected through Day 461
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=41 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=16 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs Collected Through Day 461
AESIs
|
0 Participants
|
0 Participants
|
—
|
|
(Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs Collected Through Day 461
AEs
|
19 Participants
|
12 Participants
|
—
|
|
(Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs Collected Through Day 461
SAEs
|
2 Participants
|
0 Participants
|
—
|
|
(Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs Collected Through Day 461
MAAEs
|
9 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 29, Day 91, Day 181Population: Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing.
Secondary: (Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) concentrations in serum, over time.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=299 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=154 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) Concentrations in Serum, Over Time
Day 29
|
133.4 ug/mL
Geometric Coefficient of Variation 0.72
|
21.2 ug/mL
Geometric Coefficient of Variation 0.62
|
—
|
|
(Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) Concentrations in Serum, Over Time
Day 91
|
69.6 ug/mL
Geometric Coefficient of Variation 0.82
|
14.6 ug/mL
Geometric Coefficient of Variation 0.67
|
—
|
|
(Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) Concentrations in Serum, Over Time
Day 181
|
30.3 ug/mL
Geometric Coefficient of Variation 1.64
|
6.6 ug/mL
Geometric Coefficient of Variation 1.00
|
—
|
SECONDARY outcome
Timeframe: through Day 181Population: The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
AZD3152 recipients were tested for ADA to AZD3152; EVUSHELD recipients were tested for ADA to EVUSHELD.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=297 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=151 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sub-study) Incidence of ADA to AZD3152 and EVUSHELD
|
2 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 29, Day 91, Day 181Population: Only AZD7442 group of Pharmacokinetic analysis set is eligible for the summary.
AZD7442 (ie EVUSHELD) is composed of cilgavimab and tixagevimab. This summary is only applicable to AZD7442 group.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=154 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
Tixagevimab: Day 181
|
3.5 ug/mL
Geometric Coefficient of Variation 0.89
|
—
|
—
|
|
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
Tixagevimab: Day 91
|
7.6 ug/mL
Geometric Coefficient of Variation 0.66
|
—
|
—
|
|
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
Cilgavimab: Day 29
|
8.9 ug/mL
Geometric Coefficient of Variation 0.65
|
—
|
—
|
|
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
Cilgavimab: Day 91
|
7.0 ug/mL
Geometric Coefficient of Variation 0.68
|
—
|
—
|
|
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
Cilgavimab: Day 181
|
3.2 ug/mL
Geometric Coefficient of Variation 0.84
|
—
|
—
|
|
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
Tixagevimab: Day 29
|
9.4 ug/mL
Geometric Coefficient of Variation 0.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 29, Day 91, Day 181Population: The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
ADA titers were only available for ADA positive samples.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=297 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=151 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sub-study) ADA Titers
Day 1
|
200 ADA titers
Interval 100.0 to 800.0
|
80 ADA titers
Interval 40.0 to 640.0
|
—
|
|
(Sub-study) ADA Titers
Day 29
|
NA ADA titers
All ADA results were negative, and their ADA titers were below the level of detection, so the values are NAs.
|
80 ADA titers
Interval 40.0 to 160.0
|
—
|
|
(Sub-study) ADA Titers
Day 91
|
100 ADA titers
Interval 100.0 to 100.0
|
80 ADA titers
Interval 40.0 to 160.0
|
—
|
|
(Sub-study) ADA Titers
Day 181
|
100 ADA titers
Interval 100.0 to 400.0
|
80 ADA titers
Interval 80.0 to 80.0
|
—
|
SECONDARY outcome
Timeframe: through Day 361Population: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
(Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up 12 months with all observed events at final readout) caused by any SARS-CoV-2 matched variant. First secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Matched Variant
|
59 Participants
|
56 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: through Day 361Population: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Secondary: (Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up to 12 months with all observed events at final readout) caused by any SARS-CoV-2 variants. Second secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up to 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Variants
|
175 Participants
|
147 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: through Day 361Population: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
third secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Variant Any Time up to 12 Months
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: through Day 361Population: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Secondary: (Main Cohort) Severe COVID-19 caused by any SARS-CoV-2 matched variants at any time up to 12 months through Day 361.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Matched Variants at Any Time up to 12 Months
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: through Day 361Population: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Secondary: (Main Cohort) Composite of COVID-19-related hospitalization and/or COVID-19-related death (WHO COVID-19 Clinical Progression Scale score ≥ 4) any time up to 12 months.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Composite of COVID-19-related Hospitalization and/or COVID-19-related Death (WHO COVID-19 Clinical Progression Scale Score ≥ 4) Any Time up to 12 Months
|
16 Participants
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: through Day 361Population: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
Secondary: (Main Cohort) COVID-19-related hospitalization any time up to 12 months.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) COVID-19-related Hospitalization Any Time up to 12 Months
|
16 Participants
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: through Day 361Population: SARS-CoV-2-Negative Set: all randomized participants who received part or all of the study intervention and did not have evidence of a current SARS-CoV-2 infection at baseline. Participants with positive RT-PCR test results at baseline were excluded from this analysis set.
(Main Cohort) COVID-19 related death - through Day 361
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1649 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1082 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=549 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) COVID-19 Related Death
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Day 29Population: SARS-CoV-2 nAb Set: all participants who received part or all of the study intervention and had baseline and at least one post-dose antibody measurement. Participants with protocol deviations that may interfere with serum SARS-CoV-2 nAb titers or interpretation of nAb responses may be excluded or have data collected on or after the protocol deviations be set to missing. Participants with a positive baseline central SARS-CoV-2 RT-PCR test were excluded from this analysis set.
Secondary: (Main Cohort) GMT of SARS-CoV-2 nAbs at baseline and Day 29
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1422 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1020 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=484 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
Alpha/B.1.1.7 GMT at Day 29
|
6400.09 1/dilution
Interval 5848.79 to 7003.36
|
60287.63 1/dilution
Interval 54951.89 to 66141.45
|
2932.50 1/dilution
Interval 2616.48 to 3286.7
|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
BA.2 GMT at Baseline
|
863.4 1/dilution
Interval 777.7 to 958.6
|
890.1 1/dilution
Interval 791.5 to 1001.0
|
1105.2 1/dilution
Interval 930.9 to 1312.1
|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
BA.2 GMT at Day 29
|
2928.45 1/dilution
Interval 2678.52 to 3201.71
|
8924.49 1/dilution
Interval 8141.14 to 9783.23
|
1029.20 1/dilution
Interval 918.57 to 1153.16
|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
BA.4/5 GMT at Baseline
|
679.0 1/dilution
Interval 607.2 to 759.3
|
674.0 1/dilution
Interval 593.6 to 765.3
|
846.9 1/dilution
Interval 704.1 to 1018.7
|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
BA.4/5 GMT at Day 29
|
4026.99 1/dilution
Interval 3683.4 to 4402.63
|
2975.84 1/dilution
Interval 2714.31 to 3262.57
|
840.04 1/dilution
Interval 749.95 to 940.95
|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
XBB.1.5 GMT at Baseline
|
147.5 1/dilution
Interval 134.7 to 161.5
|
135.8 1/dilution
Interval 122.7 to 150.3
|
176.6 1/dilution
Interval 150.3 to 207.5
|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
XBB.1.5 GMT at Day 29
|
2385.68 1/dilution
Interval 2143.34 to 2655.42
|
151.79 1/dilution
Interval 135.82 to 169.64
|
196.29 1/dilution
Interval 170.85 to 225.53
|
|
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
Alpha/B.1.1.7 GMT at Baseline
|
2450.5 1/dilution
Interval 2228.7 to 2694.4
|
2533.0 1/dilution
Interval 2264.7 to 2833.1
|
2861.3 1/dilution
Interval 2464.8 to 3321.5
|
SECONDARY outcome
Timeframe: at Day 29Population: SARS-CoV-2 nAb Set: all participants who received part or all of the study intervention and had baseline and at least one post-dose antibody measurement. Participants with protocol deviations that may interfere with serum SARS-CoV-2 nAb titers or interpretation of nAb responses may be excluded or have data collected on or after the protocol deviations be set to missing. Participants with a positive baseline central SARS-CoV-2 RT-PCR test were excluded from this analysis set.
Secondary: (Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=1422 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=1020 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
n=484 Participants
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
Alpha/B.1.1.7 GMFR at Day 29
|
2.54 ratio
Interval 2.33 to 2.78
|
23.97 ratio
Interval 21.85 to 26.3
|
1.17 ratio
Interval 1.04 to 1.31
|
|
(Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
BA.2 GMFR at Day 29
|
3.20 ratio
Interval 2.92 to 3.49
|
9.74 ratio
Interval 8.89 to 10.68
|
1.12 ratio
Interval 1.0 to 1.26
|
|
(Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
BA.4/5 GMFR at Day 29
|
5.68 ratio
Interval 5.2 to 6.21
|
4.20 ratio
Interval 3.83 to 4.6
|
1.19 ratio
Interval 1.06 to 1.33
|
|
(Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
XBB.1.5 GMFR at Day 29
|
15.69 ratio
Interval 14.09 to 17.46
|
1.00 ratio
Interval 0.89 to 1.12
|
1.29 ratio
Interval 1.12 to 1.48
|
SECONDARY outcome
Timeframe: through Day 361Population: Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing.
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) concentrations over time - through Day 361
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=895 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=780 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
Day 29
|
30.1 mg/L
Geometric Coefficient of Variation 35.9
|
61.0 mg/L
Geometric Coefficient of Variation 41.5
|
—
|
|
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
Day 91
|
18.2 mg/L
Geometric Coefficient of Variation 49.8
|
35.0 mg/L
Geometric Coefficient of Variation 56.8
|
—
|
|
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
Day 181
|
8.9 mg/L
Geometric Coefficient of Variation 85.9
|
15.6 mg/L
Geometric Coefficient of Variation 68.5
|
—
|
|
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
Day 189
|
33.4 mg/L
Geometric Coefficient of Variation 73.0
|
14.6 mg/L
Geometric Coefficient of Variation 72.3
|
—
|
|
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
Day 210
|
33.0 mg/L
Geometric Coefficient of Variation 50.8
|
12.5 mg/L
Geometric Coefficient of Variation 75.7
|
—
|
|
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
Day 361
|
12.0 mg/L
Geometric Coefficient of Variation 67.4
|
3.7 mg/L
Geometric Coefficient of Variation 80.7
|
—
|
SECONDARY outcome
Timeframe: through Day 361Population: The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
AZD3152 recipients were tested for ADA to AZD3152; AZD7442 recipients were tested for ADA to AZD7442.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=560 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=605 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) Incidence of ADA to AZD3152 and AZD7442 (EVUSHELD)
|
4 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 29, Day 181, Day 361Population: Pharmacokinetic analysis set: all randomized participants who received a full dose of IMP per protocol, with sufficient information to estimate at least 1 postdose quantifiable serum concentration for any mAb component. Participants with protocol deviations that may interfere with the serum concentrations may be excluded or have data collected after the protocol deviations set to missing.
AZD5156 is a combination of AZD3152 and AZD1061. This summary is only eligible for AZD5156 group.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=41 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 29 AZD5156 gluteal
|
40.1 mg/L
Geometric Coefficient of Variation 55.7
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 181 AZD5156 gluteal
|
10.7 mg/L
Geometric Coefficient of Variation 114.1
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 361 AZD5156 gluteal
|
1.9 mg/L
Geometric Coefficient of Variation 256.8
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 181 AZD5156 thigh
|
19.3 mg/L
Geometric Coefficient of Variation 107.1
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 361 AZD5156 thigh
|
3.2 mg/L
Geometric Coefficient of Variation 263.6
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 29 AZD3152 gluteal
|
21.4 mg/L
Geometric Coefficient of Variation 53.9
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 181 AZD3152 gluteal
|
6.2 mg/L
Geometric Coefficient of Variation 109.2
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 361 AZD3152 gluteal
|
1.3 mg/L
Geometric Coefficient of Variation 185.8
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 29 AZD3152 thigh
|
34.9 mg/L
Geometric Coefficient of Variation 27.1
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 181 AZD3152 thigh
|
10.4 mg/L
Geometric Coefficient of Variation 107.5
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 361 AZD3152 thigh
|
2.0 mg/L
Geometric Coefficient of Variation 188.8
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 29 AZD1061 gluteal
|
18.5 mg/L
Geometric Coefficient of Variation 61.9
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 181 AZD1061 gluteal
|
4.5 mg/L
Geometric Coefficient of Variation 123.7
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 361 AZD1061 gluteal
|
0.9 mg/L
Geometric Coefficient of Variation 149.5
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 29 AZD1061 thigh
|
36.0 mg/L
Geometric Coefficient of Variation 23.4
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 181 AZD1061 thigh
|
8.9 mg/L
Geometric Coefficient of Variation 106.9
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 361 AZD1061 thigh
|
1.6 mg/L
Geometric Coefficient of Variation 159.3
|
—
|
—
|
|
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
Day 29 AZD5156 thigh
|
71.0 mg/L
Geometric Coefficient of Variation 24.2
|
—
|
—
|
SECONDARY outcome
Timeframe: through Day 361Population: The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061 - through Day 361
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=40 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061
Treatment-emergent ADA to AZD5156 -positive
|
0 Participants
|
—
|
—
|
|
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061
Treatment-emergent ADA to AZD3152 -positive
|
0 Participants
|
—
|
—
|
|
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061
Treatment-emergent ADA to AZD1061 -positive
|
0 Participants
|
—
|
—
|
|
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061
Did not meet end point
|
40 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: through Day 361Population: The ADA analysis sets: all participants who received part or all of study intervention and had a non-missing baseline and at least one non-missing post-baseline ADA result of the same mAb component.
ADA titers were only available for ADA positive samples.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=560 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
n=605 Participants
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) ADA Titers
Baseline
|
400 ADA titers
Interval 100.0 to 1600.0
|
80 ADA titers
Interval 40.0 to 20480.0
|
—
|
|
(Main Cohort) ADA Titers
Day 29
|
200 ADA titers
Interval 100.0 to 800.0
|
80 ADA titers
Interval 40.0 to 20480.0
|
—
|
|
(Main Cohort) ADA Titers
Day 91
|
150 ADA titers
Interval 100.0 to 400.0
|
80 ADA titers
Interval 40.0 to 20480.0
|
—
|
|
(Main Cohort) ADA Titers
Day 181 (pre-dose)
|
150 ADA titers
Interval 100.0 to 400.0
|
80 ADA titers
Interval 40.0 to 20480.0
|
—
|
|
(Main Cohort) ADA Titers
Day 210
|
200 ADA titers
Interval 100.0 to 800.0
|
120 ADA titers
Interval 40.0 to 10240.0
|
—
|
|
(Main Cohort) ADA Titers
Day 361
|
250 ADA titers
Interval 100.0 to 400.0
|
80 ADA titers
Interval 40.0 to 10240.0
|
—
|
SECONDARY outcome
Timeframe: through Day 361Population: Only AZD7442 group of Pharmacokinetic analysis set is eligible for the summary.
AZD7442 (ie EVUSHELD) is composed of AZD1061 (ie, cilgavimab) and AZD8895 (ie, tixagevimab). This summary is only applicable to AZD7442 group.
Outcome measures
| Measure |
AZD3152 - Main Cohort
n=780 Participants
(AZD3152 experimental treatment)
|
AZD7442 - Main Cohort
(AZD7442 active comparator treatment)
|
Placebo - Main Cohort
(Placebo comparator treatment)
|
|---|---|---|---|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 91 AZD1061
|
17.0 mg/L
Geometric Coefficient of Variation 57.3
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 181 AZD1061
|
7.3 mg/L
Geometric Coefficient of Variation 68.0
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 189 AZD1061
|
6.8 mg/L
Geometric Coefficient of Variation 71.3
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 210 AZD1061
|
5.9 mg/L
Geometric Coefficient of Variation 70.3
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 361 AZD1061
|
1.7 mg/L
Geometric Coefficient of Variation 69.4
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 29 AZD8895
|
31.1 mg/L
Geometric Coefficient of Variation 39.0
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 91 AZD8895
|
18.0 mg/L
Geometric Coefficient of Variation 55.7
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 181 AZD8895
|
8.3 mg/L
Geometric Coefficient of Variation 67.8
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 189 AZD8895
|
7.8 mg/L
Geometric Coefficient of Variation 72.2
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 210 AZD8895
|
6.7 mg/L
Geometric Coefficient of Variation 73.4
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 361 AZD8895
|
2.2 mg/L
Geometric Coefficient of Variation 77.6
|
—
|
—
|
|
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
Day 29 AZD1061
|
30.1 mg/L
Geometric Coefficient of Variation 42.4
|
—
|
—
|
Adverse Events
AZD3152 - Main Cohort
Serious events: 315 serious events
Other events: 892 other events
Deaths: 40 deaths
AZD7442 - Main Cohort
Serious events: 222 serious events
Other events: 624 other events
Deaths: 24 deaths
Placebo - Sentinel Cohort
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
AZD3152 - Sub Study
Serious events: 15 serious events
Other events: 38 other events
Deaths: 2 deaths
AZD7442 - Sub Study
Serious events: 11 serious events
Other events: 17 other events
Deaths: 0 deaths
Crossover - Sub Study
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo - Main Cohort
Serious events: 90 serious events
Other events: 292 other events
Deaths: 6 deaths
AZD5156 - Sentinel Cohort
Serious events: 2 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
AZD3152 - Main Cohort
n=1671 participants at risk
(Including participants who received AZD3152 on Day 1 and either AZD3152 or no dose on Day 181)
|
AZD7442 - Main Cohort
n=1102 participants at risk
(Including participants who received AZD7442 on Day 1 and either placebo or no dose on Day 181)
|
Placebo - Sentinel Cohort
n=16 participants at risk
(Placebo comparator treatment)
|
AZD3152 - Sub Study
n=310 participants at risk
(AZD3152 experimental treatment)
|
AZD7442 - Sub Study
n=156 participants at risk
(AZD7442 active comparator treatment)
|
Crossover - Sub Study
n=2 participants at risk
(Including 2 immunocompromised participants who received AZD7442 at Day 1 then AZD3152 at Day 29)
|
Placebo - Main Cohort
n=561 participants at risk
(Including participants who received placebo on Day 1 and either placebo or no dose on Day 181)
|
AZD5156 - Sentinel Cohort
n=41 participants at risk
(AZD5156 experimental treatment)
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.65%
2/310 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Adhesion
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Asthenia
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Chest pain
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Death
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Gait disturbance
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
General physical health deterioration
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Generalised oedema
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Injection site necrosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Non-cardiac chest pain
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Pyrexia
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Anaphylactic reaction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Cytokine release syndrome
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Graft versus host disease
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Kidney transplant rejection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Liver transplant rejection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Abscess limb
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Anal abscess
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Appendicitis perforated
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Arthritis bacterial
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Atypical pneumonia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bacteraemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bronchitis
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bronchitis bacterial
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bronchitis haemophilus
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bronchitis pneumococcal
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Covid-19
|
0.90%
15/1671 • Number of events 15 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.91%
10/1102 • Number of events 10 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Covid-19 pneumonia
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.45%
5/1102 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.89%
5/561 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.90%
15/1671 • Number of events 18 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.00%
11/1102 • Number of events 12 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.53%
3/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Campylobacter infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Cardiac valve vegetation
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Cellulitis
|
0.36%
6/1671 • Number of events 6 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Cellulitis enterococcal
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Central nervous system infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Citrobacter bacteraemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.24%
4/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Colonic abscess
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Acute right ventricular failure
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Cystitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Device related infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Diarrhoea infectious
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Disseminated cryptococcosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Angina pectoris
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Diverticulitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Emphysematous cystitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Empyema
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Encephalomyelitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Endocarditis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Epididymitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Hypotension
|
0.48%
8/1671 • Number of events 9 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Epstein-barr virus infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Escherichia sepsis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Gastroenteritis
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Groin abscess
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Herpes zoster
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Influenza
|
0.36%
6/1671 • Number of events 6 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Jc virus infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Atrial fibrillation
|
0.72%
12/1671 • Number of events 13 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
7/1102 • Number of events 8 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Localised infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Measles
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Medical device site joint infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Atrial flutter
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Osteomyelitis
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Otitis media
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Peritonitis
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Peritonitis bacterial
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pilonidal disease
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumococcal infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia
|
1.9%
32/1671 • Number of events 34 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.4%
15/1102 • Number of events 15 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.1%
6/561 • Number of events 6 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia bacterial
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia necrotising
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia serratia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pneumonia viral
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pyelonephritis
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pyelonephritis acute
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Bradycardia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Pyomyositis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Renal graft infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Rickettsiosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Sepsis
|
0.72%
12/1671 • Number of events 12 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.82%
9/1102 • Number of events 9 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.71%
4/561 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Cardiac arrest
|
0.42%
7/1671 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Septic pulmonary embolism
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Septic shock
|
0.84%
14/1671 • Number of events 15 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.53%
3/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Stenotrophomonas maltophilia pneumonia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Streptococcal sepsis
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Cardiac failure
|
0.06%
1/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Urinary tract infection
|
0.48%
8/1671 • Number of events 9 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.54%
6/1102 • Number of events 6 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Urinary tract infection fungal
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Urosepsis
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Varicella
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Vascular access site cellulitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Cardiac failure acute
|
0.48%
8/1671 • Number of events 9 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Wound cellulitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Wound infection
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
3/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.54%
6/1102 • Number of events 6 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.66%
11/1671 • Number of events 12 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.91%
10/1102 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Cardiac valve disease
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Cardiogenic shock
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Renal transplant failure
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Spleen contusion
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Coronary artery disease
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Vascular access site thrombosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Heart failure with preserved ejection fraction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Investigations
Influenza a virus test positive
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Investigations
International normalised ratio increased
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Investigations
Troponin increased
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Investigations
White blood cell count decreased
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Heart failure with reduced ejection fraction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.53%
3/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.48%
8/1671 • Number of events 8 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.73%
8/1102 • Number of events 12 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.66%
11/1671 • Number of events 13 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.91%
10/1102 • Number of events 14 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Hypertensive heart disease
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Immunoglobulin g4 related disease
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia refractory
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large cell lymphoma t- and null-cell types
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Autoimmune neutropenia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Myocardial infarction
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Pericardial effusion
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma stage iv
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High-grade b-cell lymphoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive breast cancer
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma recurrent
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage iv
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage iv
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma metastatic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Ataxia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Brain injury
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Brain stem infarction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Brain stem stroke
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Carotid artery disease
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Eye disorders
Cataract
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Central nervous system lupus
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Cerebral infarction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Cerebral microinfarction
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
6/1671 • Number of events 6 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Embolic stroke
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Encephalopathy
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Facial paralysis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Eye disorders
Glaucoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Headache
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Intracranial aneurysm
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Ischaemic stroke
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.18%
3/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Migraine
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Multiple sclerosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Myelopathy
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Seizure
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Syncope
|
0.42%
7/1671 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Tension headache
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Hypertension
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Vith nerve paralysis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Product Issues
Device malfunction
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Psychiatric disorders
Mental status changes
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Psychiatric disorders
Suicide attempt
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.66%
11/1671 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.73%
8/1102 • Number of events 10 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.71%
4/561 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
End stage renal disease
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Lupus nephritis
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Renal failure
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Renal infarct
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Renal mass
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.42%
7/1671 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.82%
9/1102 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.53%
3/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic rhinosinusitis with nasal polyps
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pleurisy
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.18%
3/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.48%
8/1671 • Number of events 8 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.65%
2/310 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.42%
7/1671 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Aneurysm ruptured
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Aortic stenosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Aortitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Arterial thrombosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Brachiocephalic vein thrombosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Dialysis hypotension
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Haematoma
|
0.06%
1/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Hypertensive crisis
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Hypertensive emergency
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.54%
6/1102 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Hypertensive urgency
|
0.06%
1/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Hypovolaemic shock
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Jugular vein thrombosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Peripheral ischaemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Peripheral venous disease
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Raynaud's phenomenon
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Shock haemorrhagic
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Venous stenosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Abdominal wall cyst
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Ascites
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Colitis
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.36%
6/1671 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.45%
5/1102 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Faecaloma
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Femoral hernia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Food poisoning
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Gastritis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Immune-mediated pancytopenia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Ileus
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
50.0%
1/2 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Large intestinal ulcer perforation
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Nausea
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Oral macule
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
Other adverse events
| Measure |
AZD3152 - Main Cohort
n=1671 participants at risk
(Including participants who received AZD3152 on Day 1 and either AZD3152 or no dose on Day 181)
|
AZD7442 - Main Cohort
n=1102 participants at risk
(Including participants who received AZD7442 on Day 1 and either placebo or no dose on Day 181)
|
Placebo - Sentinel Cohort
n=16 participants at risk
(Placebo comparator treatment)
|
AZD3152 - Sub Study
n=310 participants at risk
(AZD3152 experimental treatment)
|
AZD7442 - Sub Study
n=156 participants at risk
(AZD7442 active comparator treatment)
|
Crossover - Sub Study
n=2 participants at risk
(Including 2 immunocompromised participants who received AZD7442 at Day 1 then AZD3152 at Day 29)
|
Placebo - Main Cohort
n=561 participants at risk
(Including participants who received placebo on Day 1 and either placebo or no dose on Day 181)
|
AZD5156 - Sentinel Cohort
n=41 participants at risk
(AZD5156 experimental treatment)
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.0%
34/1671 • Number of events 38 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.5%
17/1102 • Number of events 17 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.0%
11/561 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Asthenia
|
2.3%
39/1671 • Number of events 40 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
26/1102 • Number of events 29 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.4%
8/561 • Number of events 8 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Fatigue
|
5.9%
98/1671 • Number of events 109 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.3%
69/1102 • Number of events 77 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.3%
4/310 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.3%
2/156 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
35/561 • Number of events 39 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Injection site pain
|
2.0%
33/1671 • Number of events 34 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.6%
29/1102 • Number of events 33 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
12.5%
2/16 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.2%
7/561 • Number of events 8 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.9%
2/41 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Injection site pruritus
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Non-cardiac chest pain
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
4/1102 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Peripheral swelling
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
General disorders
Pyrexia
|
3.2%
53/1671 • Number of events 62 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.9%
43/1102 • Number of events 45 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.7%
15/561 • Number of events 20 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Bronchitis
|
2.9%
49/1671 • Number of events 56 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.7%
30/1102 • Number of events 33 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.2%
7/561 • Number of events 8 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Covid-19
|
16.3%
273/1671 • Number of events 293 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
18.6%
205/1102 • Number of events 218 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.97%
3/310 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.6%
4/156 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
20.0%
112/561 • Number of events 116 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Conjunctivitis
|
1.0%
17/1671 • Number of events 17 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.1%
12/1102 • Number of events 12 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.53%
3/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Gastroenteritis viral
|
0.18%
3/1671 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Influenza
|
2.2%
37/1671 • Number of events 38 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.3%
14/1102 • Number of events 14 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.4%
8/561 • Number of events 8 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
77/1671 • Number of events 85 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.7%
41/1102 • Number of events 45 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.3%
24/561 • Number of events 27 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.12%
2/1671 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Rhinitis
|
2.5%
41/1671 • Number of events 47 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.5%
27/1102 • Number of events 32 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.8%
10/561 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Sinusitis
|
3.0%
50/1671 • Number of events 62 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.1%
34/1102 • Number of events 42 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.2%
18/561 • Number of events 21 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
121/1671 • Number of events 150 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
5.7%
63/1102 • Number of events 69 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.97%
3/310 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
7.8%
44/561 • Number of events 50 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
12.2%
5/41 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Ureaplasma infection
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Urinary tract infection
|
5.2%
87/1671 • Number of events 125 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
5.4%
60/1102 • Number of events 85 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.97%
3/310 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.8%
27/561 • Number of events 31 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.1%
19/1671 • Number of events 25 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.00%
11/1102 • Number of events 15 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
18.8%
3/16 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.6%
9/561 • Number of events 10 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.60%
10/1671 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.00%
11/1102 • Number of events 13 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.2%
7/561 • Number of events 9 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
39/1671 • Number of events 41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.3%
25/1102 • Number of events 26 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.5%
14/561 • Number of events 14 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Investigations
Sars-cov-2 test positive
|
1.7%
29/1671 • Number of events 29 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.1%
23/1102 • Number of events 23 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.53%
3/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
34/1671 • Number of events 39 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.0%
22/1102 • Number of events 24 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.6%
9/561 • Number of events 10 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
20/1671 • Number of events 20 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.3%
25/1102 • Number of events 25 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.2%
18/561 • Number of events 20 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
37/1671 • Number of events 39 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.9%
32/1102 • Number of events 36 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.65%
2/310 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.0%
17/561 • Number of events 19 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.4%
24/1671 • Number of events 35 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.3%
25/1102 • Number of events 33 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.1%
12/561 • Number of events 17 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Headache
|
7.7%
128/1671 • Number of events 154 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
7.5%
83/1102 • Number of events 97 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
18.8%
3/16 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.6%
5/310 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.3%
2/156 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.4%
36/561 • Number of events 46 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
9.8%
4/41 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Migraine
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.45%
5/1102 • Number of events 6 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.89%
5/561 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Nervous system disorders
Syncope
|
0.48%
8/1671 • Number of events 9 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.27%
3/1102 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Renal and urinary disorders
Haematuria
|
0.18%
3/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.32%
1/310 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.36%
2/561 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Vascular disorders
Hypertension
|
3.1%
51/1671 • Number of events 54 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.6%
40/1102 • Number of events 41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.6%
5/310 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
50.0%
1/2 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.7%
21/561 • Number of events 22 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
144/1671 • Number of events 170 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
10.1%
111/1102 • Number of events 135 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.5%
25/561 • Number of events 33 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.5%
58/1671 • Number of events 62 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.5%
27/1102 • Number of events 33 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.3%
13/561 • Number of events 13 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
96/1671 • Number of events 119 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
5.3%
58/1102 • Number of events 70 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.3%
2/156 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.9%
22/561 • Number of events 24 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.9%
2/41 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.2%
70/1671 • Number of events 85 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
5.4%
59/1102 • Number of events 68 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.2%
18/561 • Number of events 20 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.06%
1/1671 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.97%
3/310 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.09%
1/1102 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
22/1671 • Number of events 22 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.73%
8/1102 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
1.1%
6/561 • Number of events 10 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.30%
5/1671 • Number of events 5 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
1/561 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
72/1671 • Number of events 78 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.8%
53/1102 • Number of events 65 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
6.2%
1/16 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.3%
7/310 • Number of events 7 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
50.0%
1/2 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.1%
23/561 • Number of events 27 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/41 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Food poisoning
|
0.24%
4/1671 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/1102 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.53%
3/561 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.84%
14/1671 • Number of events 14 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.91%
10/1102 • Number of events 11 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.71%
4/561 • Number of events 4 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
4.9%
2/41 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Nausea
|
3.2%
54/1671 • Number of events 57 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.1%
34/1102 • Number of events 35 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.97%
3/310 • Number of events 3 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.64%
1/156 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
3.0%
17/561 • Number of events 19 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1671 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.18%
2/1102 • Number of events 2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/16 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/310 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/156 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/2 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
0.00%
0/561 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
2.4%
1/41 • Number of events 1 • through Day 451 for Main Cohort; through Day 361 for Sentinel Cohort; through Day 451 for Sub study SAEs/deaths; through Day 29 for Sub study non-serious AEs.
The grouping for main cohort aligns with the prespecified groups for the overall reporting period in SAP: "Both/One Dose: AZD3152" (labeled as AZD3152 - Main Cohort), "One Dose: AZD7442" (labeled as AZD7442 - Main Cohort), and "Both/One Dose: Placebo" (labeled as Placebo - Main Cohort).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place