Trial Outcomes & Findings for Evaluation of ADG20 for the Prevention of COVID-19 (NCT NCT04859517)
NCT ID: NCT04859517
Last Updated: 2024-08-20
Results Overview
RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
2582 participants
Primary outcome timeframe
Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
ADG20 IM - Cohort A
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
245
|
242
|
1048
|
1047
|
|
Overall Study
COMPLETED
|
32
|
35
|
226
|
236
|
|
Overall Study
NOT COMPLETED
|
213
|
207
|
822
|
811
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of ADG20 for the Prevention of COVID-19
Baseline characteristics by cohort
| Measure |
ADG20 IM - Cohort A
n=245 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=242 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
n=1048 Participants
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
n=1047 Participants
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
Total
n=2582 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
16 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
209 Participants
n=99 Participants
|
220 Participants
n=107 Participants
|
942 Participants
n=206 Participants
|
923 Participants
n=157 Participants
|
2294 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
122 Participants
n=157 Participants
|
272 Participants
n=390 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 15.61 • n=99 Participants
|
45.4 years
STANDARD_DEVIATION 14.52 • n=107 Participants
|
46.5 years
STANDARD_DEVIATION 13.90 • n=206 Participants
|
47.1 years
STANDARD_DEVIATION 14.10 • n=157 Participants
|
46.8 years
STANDARD_DEVIATION 14.00 • n=390 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
508 Participants
n=206 Participants
|
522 Participants
n=157 Participants
|
1273 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
540 Participants
n=206 Participants
|
525 Participants
n=157 Participants
|
1309 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
146 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
248 Participants
n=157 Participants
|
754 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
785 Participants
n=206 Participants
|
751 Participants
n=157 Participants
|
1734 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
48 Participants
n=157 Participants
|
94 Participants
n=390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
17 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
18 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
13 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
182 Participants
n=157 Participants
|
409 Participants
n=390 Participants
|
|
Race (NIH/OMB)
White
|
214 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
821 Participants
n=206 Participants
|
803 Participants
n=157 Participants
|
2048 Participants
n=390 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
27 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
50 Participants
n=390 Participants
|
|
Region of Enrollment
Argentina
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
7 participants
n=157 Participants
|
14 participants
n=390 Participants
|
|
Region of Enrollment
Romania
|
43 participants
n=99 Participants
|
36 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=157 Participants
|
79 participants
n=390 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=99 Participants
|
180 participants
n=107 Participants
|
870 participants
n=206 Participants
|
868 participants
n=157 Participants
|
2098 participants
n=390 Participants
|
|
Region of Enrollment
Czechia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
5 participants
n=157 Participants
|
8 participants
n=390 Participants
|
|
Region of Enrollment
Ukraine
|
22 participants
n=99 Participants
|
25 participants
n=107 Participants
|
82 participants
n=206 Participants
|
81 participants
n=157 Participants
|
210 participants
n=390 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
17 participants
n=206 Participants
|
16 participants
n=157 Participants
|
33 participants
n=390 Participants
|
|
Region of Enrollment
Moldova
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
5 participants
n=206 Participants
|
2 participants
n=157 Participants
|
7 participants
n=390 Participants
|
|
Region of Enrollment
Georgia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
65 participants
n=206 Participants
|
68 participants
n=157 Participants
|
133 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=175 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=176 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
|
3 Participants
|
12 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=752 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=728 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)
|
12 Participants
|
40 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 4Population: Participants who received any amount of study drug
Percentage of participants with at least one solicited injection site reaction
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=240 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=241 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
n=1001 Participants
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
n=1001 Participants
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Solicited Injection Site Reactions (PEP, PrEP)
|
12 Participants
|
7 Participants
|
75 Participants
|
73 Participants
|
PRIMARY outcome
Timeframe: Day 1 through 14 Months or 25Jul2022, whichever is earlierPopulation: Participants who received any amount of study drug
Any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment; includes solicited injection site reactions
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=240 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=241 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
n=1001 Participants
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
n=1001 Participants
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)
|
42 Participants
|
51 Participants
|
399 Participants
|
362 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCRtest from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=76 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=79 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
|
1 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Participants with RT-PCR-confirmed symptomatic COVID-19 (protocol defined COVID-19 symptoms occurring within 14 days from the sample collection date of a positive central or local \[in the absence of central test\] RT-PCR, any COVID-19-related hospitalization with a positive local SARS-CoV-2 test \[within 14 days\], or all-cause death), central RT-PCR-confirmed SARS-CoV-2 infection, or central serology-confirmed SARS-CoV-2 infection with negative central serology at baseline.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=175 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=176 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP)
|
6 Participants
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Defined as having a central RT-qPCR-confirmed SARS-CoV-2 infection without having an RT-PCR-confirmed symptomatic COVID-19 outcome
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=175 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=176 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP)
|
3 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Defined as having a central serology-confirmed SARS-CoV-2 infection (with a negative central serology test sample at baseline) and without having an RT-PCR-confirmed symptomatic COVID-19 outcome (including COVID-19-related hospitalization and all-cause death)
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=175 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=176 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP)
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 6 Months or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Defined as having a central serology-confirmed SARS-CoV-2 infection (with a negative central serology test sample at baseline) and without having an RT-PCR-confirmed symptomatic COVID-19 outcome (including COVID-19-related hospitalization and all-cause death)
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=752 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=728 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP)
|
10 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants with RT-qPCR-confirmed asymptomatic SARS-CoV-2 infection in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Asymptomatic SARS-CoV-2 infection confirmed by RT-qPCR from nasal swab collected at Day 8 and Day 15. Viral load values reported as detected but below the lower quantification of the PCR assay (\< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as \> 7.1×10\^7 copies/mL are imputed with 7.1×10\^7 copies/mL (i.e., 7.85 log10 copies/mL).
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=3 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=1 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)
Day 8
|
2.96 Viral load (log10 copies/mL)
Standard Deviation 4.186
|
0 Viral load (log10 copies/mL)
Standard Deviation 0
|
—
|
—
|
|
SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)
Day 15
|
2.15 Viral load (log10 copies/mL)
Standard Deviation 1.985
|
3.16 Viral load (log10 copies/mL)
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Maximum severity assessed from COVID-19-like illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=3 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=12 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)
Cohort A (PEP) Mild
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)
Cohort A (PEP) Moderate
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)
Cohort A (PEP) Severe/Critical
|
0 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Maximum severity assessed from COVID-19-like Illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=12 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=40 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)
Cohort B (PrEP) Mild
|
7 Participants
|
14 Participants
|
—
|
—
|
|
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)
Cohort B (PrEP) Moderate
|
4 Participants
|
19 Participants
|
—
|
—
|
|
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)
Cohort B (PrEP) Severe/Critical
|
1 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR-confirmed symptomatic COVID-19 events, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=3 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=12 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP)
|
0 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR confirmed symptomatic COVID-19, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=12 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=40 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP)
|
1 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Day 28 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=3 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=12 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With a COVID-19 Related Hospitalization (PEP)
|
0 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 28 days from COVID-19-like illness initial visit (CLI Day 1)Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=12 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=40 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)
|
1 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)Population: Participants with RT- PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=3 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=12 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
COVID-19 Related Mortality (PEP)
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=12 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=40 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
COVID-19 Related Mortality (PrEP)
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Day 28 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=3 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=12 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
All-Cause Mortality (PEP)
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): PrEP participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=12 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=40 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
All-Cause Mortality (PrEP)
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Positive CLI Day 1 sample through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants with RT-PCR confirmed symptomatic COVID-19 through Day 28 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Viral load from COVID-19-like illness (CLI) Day 1 sample. Viral load values reported as detected but below the lower quantification of the PCR assay (\< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as \> 7.1×10\^7 copies/mL are imputed with 7.1×10\^7 copies/mL (i.e., 7.85 log10 copies/mL).
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=3 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=12 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP)
|
2.43 log10 copies/mL
Standard Deviation 2.372
|
5.74 log10 copies/mL
Standard Deviation 2.689
|
—
|
—
|
SECONDARY outcome
Timeframe: Positive CLI Day 1 sample through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlierPopulation: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Viral load from COVID-19-like Illness (CLI) Day 1 sample. Viral load values reported as detected but below the lower quantification of the PCR assay (\< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as \> 7.1×10\^7 copies/mL are imputed with 7.1×10\^7 copies/mL (i.e., 7.85 log10 copies/mL).
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=12 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=40 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP)
|
4.58 Log10 copies/mL
Standard Deviation 2.730
|
6.58 Log10 copies/mL
Standard Deviation 1.825
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlierPopulation: Participants who received study drug and have measurable ADG20 concentration data for at least 2 post-injection time points
PK samples collected at protocol-defined timepoints
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=52 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)
Day 8
|
36.3 ug/mL
Standard Deviation 15.4
|
—
|
—
|
—
|
|
Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)
Day 28
|
33.6 ug/mL
Standard Deviation 12.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlierPopulation: Participants who received study drug and have measurable ADG20 concentration data for at least 2 post-injection time points
PK samples collected at protocol-defined timepoints
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=353 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)
Day 8
|
38.2 ug/mL
Standard Deviation 14.7
|
—
|
—
|
—
|
|
Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)
Day 28
|
33.6 ug/mL
Standard Deviation 12.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: An average of 2 months up to 7 months through cutoff date prior to emergence of Omicron (15-Dec-2021)Population: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measure is presented as cumulative probability expressed in percentage. RT-PCR-confirmed symptomatic COVID-19 event is defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=175 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=176 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)
Day 28
|
1.74 Percent probability
|
7.01 Percent probability
|
—
|
—
|
|
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)
Day 60
|
1.74 Percent probability
|
7.84 Percent probability
|
—
|
—
|
|
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)
Day 90
|
1.74 Percent probability
|
7.84 Percent probability
|
—
|
—
|
SECONDARY outcome
Timeframe: An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)Population: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
Outcome measure is presented as cumulative probability expressed in percentage. RT-PCR-confirmed symptomatic COVID-19 event is defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.
Outcome measures
| Measure |
ADG20 IM - Cohort A
n=752 Participants
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=728 Participants
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were administered a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)
Day 28
|
0.96 Percent probability
|
2.32 Percent probability
|
—
|
—
|
|
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)
Day 60
|
1.31 Percent probability
|
5.64 Percent probability
|
—
|
—
|
|
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)
Day 90
|
2.01 Percent probability
|
7.26 Percent probability
|
—
|
—
|
Adverse Events
ADG20 IM - Cohort A
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo IM - Cohort A
Serious events: 8 serious events
Other events: 0 other events
Deaths: 2 deaths
ADG20 IM - Cohort B
Serious events: 46 serious events
Other events: 126 other events
Deaths: 3 deaths
Placebo IM - Cohort B
Serious events: 46 serious events
Other events: 123 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
ADG20 IM - Cohort A
n=240 participants at risk
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=241 participants at risk
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
n=1001 participants at risk
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
n=1001 participants at risk
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.42%
1/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
1.7%
4/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.90%
9/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Pneumonia
|
0.42%
1/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.40%
4/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.20%
2/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Influenza
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.41%
1/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.41%
1/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.41%
1/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.20%
2/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.41%
1/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.42%
1/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Metabolism and nutrition disorders
Gout
|
0.42%
1/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.20%
2/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
COVID-19
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.30%
3/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.60%
6/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Sepsis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Testicular abscess
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Shrapnel wound
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Meniscus cyst
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage II
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hairy cell leukaemia
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.20%
2/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.20%
2/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.20%
2/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Substance-induced mood disorder
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Schizoaffective disorder depressive type
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Depression
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.20%
2/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Eye disorders
Visual field defect
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.10%
1/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
Other adverse events
| Measure |
ADG20 IM - Cohort A
n=240 participants at risk
ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort A
n=241 participants at risk
Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
ADG20 IM - Cohort B
n=1001 participants at risk
ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1.
|
Placebo IM - Cohort B
n=1001 participants at risk
Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1.
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
7.6%
76/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
8.4%
84/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
|
General disorders
Influenza like illness
|
0.00%
0/240 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
0.00%
0/241 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
5.9%
59/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
4.6%
46/1001 • Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier
Safety analysis set: All participants who received any amount of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place