Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis (NCT NCT04163991)
NCT ID: NCT04163991
Last Updated: 2024-12-17
Results Overview
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity. Results are from a mixed-effect model for repeated measures (MMRM) analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Day 1 (Baseline), Day 113
Results posted on
2024-12-17
Participant Flow
After a screening period of up to 28 days, eligible participants were randomized in a 1:1:1:1:1 ratio into 5 cohorts.
Participant milestones
| Measure |
Placebo
Participants received intravenous (IV) infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
VIB4920 1500 mg Twice
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
13
|
11
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
5
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received intravenous (IV) infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
VIB4920 1500 mg Twice
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
1
|
1
|
|
Overall Study
Other, Not Specified
|
0
|
1
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=16 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
VIB4920 1500 mg Twice
n=16 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=15 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
56.4 years
STANDARD_DEVIATION 15.2 • n=21 Participants
|
56.3 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
73 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
|
5.443 score on a scale
STANDARD_DEVIATION 1.066 • n=5 Participants
|
5.473 score on a scale
STANDARD_DEVIATION 0.883 • n=7 Participants
|
5.945 score on a scale
STANDARD_DEVIATION 0.736 • n=5 Participants
|
5.452 score on a scale
STANDARD_DEVIATION 0.644 • n=4 Participants
|
5.761 score on a scale
STANDARD_DEVIATION 0.711 • n=21 Participants
|
5.615 score on a scale
STANDARD_DEVIATION 0.830 • n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline), Day 113Population: Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized. Participants with an assessment at given time point by group.
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity. Results are from a mixed-effect model for repeated measures (MMRM) analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=15 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=14 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=15 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 113 in DAS28-CRP
|
-1.87 score on a scale
Standard Error 0.27
|
-1.87 score on a scale
Standard Error 0.27
|
-1.83 score on a scale
Standard Error 0.28
|
-1.06 score on a scale
Standard Error 0.26
|
-1.90 score on a scale
Standard Error 0.27
|
PRIMARY outcome
Timeframe: From first dose of study drug through Day 309 ± 7 daysPopulation: Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
Adverse event (AE): any untoward medical occurrence associated with the use of an intervention in humans, whether or not it is considered intervention-related. Serious adverse event (SAE): an AE that results in any of the following outcomes: death; life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity; congenital anomaly/birth defect; other important medical event jeopardizing the participant's well-being. AEs of special interest (AESIs) include: thrombotic and embolic events; anaphylaxis and clinically significant (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or higher) hypersensitivity reactions; severe infusion-related reactions (CTCAE Grade 3 or higher); immune complex disease; severe (CTCAE Grade 3 or higher) and/or opportunistic infections; hepatic function abnormality meeting the definition of Hy's Law; malignant neoplasm. (CTCAE Grade 3=Severe; Grade 4=Life-threatening; Grade 5=Fatal.)
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=17 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=14 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=18 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one event of ≥ Grade 3 severity
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one serious event
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one event
|
14 Participants
|
11 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one study drug-related event
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Death (Grade 5 severity)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one event leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one event of special interest
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one serious and/or ≥ Grade 3 severity event
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
At least one related serious event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7dPopulation: PK Analysis Set: Participants who received active study drug and had at least one quantifiable plasma PK observation post-first dose. Participants were analyzed according to the treatment that they actually received. Participants with an assessment at given dose time points by group.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=17 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax)
Dose 1
|
860 μg/mL
Standard Deviation 275
|
421 μg/mL
Standard Deviation 102
|
—
|
877 μg/mL
Standard Deviation 204
|
476 μg/mL
Standard Deviation 127
|
|
Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax)
Dose 2
|
1050 μg/mL
Standard Deviation 349
|
564 μg/mL
Standard Deviation 163
|
—
|
—
|
504 μg/mL
Standard Deviation 162
|
|
Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax)
Dose 3
|
—
|
601 μg/mL
Standard Deviation 181
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax)
Dose 4
|
—
|
568 μg/mL
Standard Deviation 140
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7dPopulation: PK Analysis Set: Participants who received active study drug and had at least one quantifiable plasma PK observation post-first dose. Participants were analyzed according to the treatment that they actually received. Participants with an assessment at given dose time points by group.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=17 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
PK of VIB4920: Time to Cmax (Tmax)
Dose 1
|
0.0875 day
Interval 0.084 to 0.0917
|
0.0903 day
Interval 0.084 to 0.108
|
—
|
0.0899 day
Interval 0.0868 to 0.1
|
0.0875 day
Interval 0.0847 to 0.0951
|
|
PK of VIB4920: Time to Cmax (Tmax)
Dose 2
|
0.0667 day
Interval 0.0486 to 0.0882
|
0.0486 day
Interval 0.0437 to 0.0521
|
—
|
—
|
0.0681 day
Interval 0.0646 to 0.0847
|
|
PK of VIB4920: Time to Cmax (Tmax)
Dose 3
|
—
|
0.0472 day
Interval 0.0438 to 0.0486
|
—
|
—
|
—
|
|
PK of VIB4920: Time to Cmax (Tmax)
Dose 4
|
—
|
0.0667 day
Interval 0.0486 to 0.0708
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7dPopulation: PK Analysis Set: Participants who received active study drug and had at least one quantifiable plasma PK observation post-first dose. Participants were analyzed according to the treatment that they actually received. Participants with an assessment at given dose time points by group.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=17 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Dose 1
|
7870 μg·day/mL
Standard Deviation 2570
|
2960 μg·day/mL
Standard Deviation 604
|
—
|
7350 μg·day/mL
Standard Deviation 1380
|
3980 μg·day/mL
Standard Deviation 1580
|
|
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Dose 2
|
10000 μg·day/mL
Standard Deviation 3320
|
4060 μg·day/mL
Standard Deviation 1290
|
—
|
—
|
5280 μg·day/mL
Standard Deviation 2000
|
|
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Dose 3
|
—
|
6350 μg·day/mL
Standard Deviation 1840
|
—
|
—
|
—
|
|
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Dose 4
|
—
|
5770 μg·day/mL
Standard Deviation 1110
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), Day 56Population: PK Analysis Set: Participants who received active study drug and had at least one quantifiable plasma PK observation post-first dose. Participants were analyzed according to the treatment that they actually received. Participants with an assessment at given dose time points by group. Per protocol, due to the nature of the dosing and sampling for the VIB4920 1500 mg 4 Times arm, this analysis was not done.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to Day 56 (AUC0-56D)
Dose 1
|
7870 μg·day/mL
Standard Deviation 2570
|
—
|
—
|
7280 μg·day/mL
Standard Deviation 1370
|
4280 μg·day/mL
Standard Deviation 1280
|
|
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to Day 56 (AUC0-56D)
Dose 2
|
9910 μg·day/mL
Standard Deviation 3250
|
—
|
—
|
—
|
5310 μg·day/mL
Standard Deviation 2000
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7dPopulation: PK Analysis Set: Participants who received active study drug and had at least one quantifiable plasma PK observation post-first dose. Participants were analyzed according to the treatment that they actually received. Participants with an assessment at given dose time points by group. Per protocol, due to the nature of the dosing and sampling for the VIB4920 1500 mg 4 Times arm, this analysis was done for Dose 4 only.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=15 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
PK of VIB4920: Total Body Clearance (CL) for Dose 1 and Total Body Clearance at Steady State (CLss) for Doses 2 to 4
Dose 1 (CL)
|
417 mL/day
Standard Deviation 144
|
—
|
—
|
430 mL/day
Standard Deviation 91.9
|
371 mL/day
Standard Deviation 92.5
|
|
PK of VIB4920: Total Body Clearance (CL) for Dose 1 and Total Body Clearance at Steady State (CLss) for Doses 2 to 4
Dose 2 (CLss)
|
340 mL/day
Standard Deviation 140
|
—
|
—
|
—
|
314 mL/day
Standard Deviation 104
|
|
PK of VIB4920: Total Body Clearance (CL) for Dose 1 and Total Body Clearance at Steady State (CLss) for Doses 2 to 4
Dose 4 (CLss)
|
—
|
294 mL/day
Standard Deviation 49.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7dPopulation: PK Analysis Set: Participants who received active study drug and had at least one quantifiable plasma PK observation post-first dose. Participants were analyzed according to the treatment that they actually received. Participants with an assessment at given dose time points by group. Per protocol, due to the nature of the dosing and sampling for the VIB4920 1500 mg 4 Times arm, this analysis was done for Dose 4 only.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
PK of VIB4920: Terminal Elimination Half-Life (t1/2)
Dose 1
|
9.02 day
Standard Deviation 1.06
|
—
|
—
|
9.27 day
Standard Deviation 1.61
|
9.06 day
Standard Deviation 1.98
|
|
PK of VIB4920: Terminal Elimination Half-Life (t1/2)
Dose 2
|
9.88 day
Standard Deviation 1.41
|
—
|
—
|
—
|
9.55 day
Standard Deviation 1.51
|
|
PK of VIB4920: Terminal Elimination Half-Life (t1/2)
Dose 4
|
—
|
10.5 day
Standard Deviation 2.06
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7dPopulation: PK Analysis Set: Participants who received active study drug and had at least one quantifiable plasma PK observation post-first dose. Participants were analyzed according to the treatment that they actually received. Participants with an assessment at given dose time points by group. Per protocol, due to the nature of the dosing and sampling for the VIB4920 1500 mg 4 Times arm, this analysis was done for Dose 4 only.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=15 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
PK of VIB4920: Volume of Distribution at Steady State (Vss)
Dose 1
|
4540 mL
Standard Deviation 1470
|
—
|
—
|
4350 mL
Standard Deviation 1300
|
3750 mL
Standard Deviation 601
|
|
PK of VIB4920: Volume of Distribution at Steady State (Vss)
Dose 2
|
3600 mL
Standard Deviation 1720
|
—
|
—
|
—
|
3490 mL
Standard Deviation 926
|
|
PK of VIB4920: Volume of Distribution at Steady State (Vss)
Dose 4
|
—
|
3210 mL
Standard Deviation 865
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Days 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309Population: Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized. Participants with an assessment at given time point by group.
Total sCD40L (free sCD40L and sCD40L bound to VIB4920) was measured in plasma samples using a modified commercially available kit.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=16 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=15 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=16 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 15
|
36.0088 ng/mL
Standard Deviation 14.4324
|
28.2492 ng/mL
Standard Deviation 10.4252
|
33.9007 ng/mL
Standard Deviation 8.7777
|
4.6759 ng/mL
Standard Deviation 3.6596
|
30.7744 ng/mL
Standard Deviation 7.4954
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 29
|
66.7047 ng/mL
Standard Deviation 15.3708
|
68.0636 ng/mL
Standard Deviation 28.6523
|
68.1386 ng/mL
Standard Deviation 12.1314
|
4.8431 ng/mL
Standard Deviation 3.3770
|
67.5427 ng/mL
Standard Deviation 16.4322
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 57
|
62.5560 ng/mL
Standard Deviation 14.4445
|
63.6939 ng/mL
Standard Deviation 25.5500
|
64.1329 ng/mL
Standard Deviation 12.4842
|
0.8150 ng/mL
Standard Deviation 1.6053
|
64.4177 ng/mL
Standard Deviation 16.4322
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 85
|
77.5360 ng/mL
Standard Deviation 18.7440
|
57.2587 ng/mL
Standard Deviation 20.0742
|
69.8821 ng/mL
Standard Deviation 19.2623
|
0.4483 ng/mL
Standard Deviation 1.1842
|
53.1583 ng/mL
Standard Deviation 20.6513
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 113
|
75.4407 ng/mL
Standard Deviation 18.2921
|
53.4514 ng/mL
Standard Deviation 26.2712
|
68.5636 ng/mL
Standard Deviation 19.3458
|
0.3420 ng/mL
Standard Deviation 1.3246
|
21.4686 ng/mL
Standard Deviation 19.3705
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 141
|
55.4204 ng/mL
Standard Deviation 28.9470
|
53.2827 ng/mL
Standard Deviation 31.6165
|
52.3943 ng/mL
Standard Deviation 29.4422
|
0.2547 ng/mL
Standard Deviation 0.9863
|
1.6517 ng/mL
Standard Deviation 3.7565
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 169
|
21.1296 ng/mL
Standard Deviation 27.1973
|
18.3170 ng/mL
Standard Deviation 20.2842
|
23.5727 ng/mL
Standard Deviation 26.0510
|
0.3114 ng/mL
Standard Deviation 1.1653
|
0 ng/mL
Standard Deviation 0
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 197
|
4.4354 ng/mL
Standard Deviation 9.9146
|
2.5057 ng/mL
Standard Deviation 4.4880
|
4.6343 ng/mL
Standard Deviation 5.3603
|
0.2757 ng/mL
Standard Deviation 1.0316
|
0 ng/mL
Standard Deviation 0
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 225
|
-0.4043 ng/mL
Standard Deviation 1.5127
|
-0.0137 ng/mL
Standard Deviation 1.1940
|
-0.2971 ng/mL
Standard Deviation 0.8718
|
0.2450 ng/mL
Standard Deviation 0.9167
|
0 ng/mL
Standard Deviation 0
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 253
|
-0.5946 ng/mL
Standard Deviation 2.1439
|
-0.5292 ng/mL
Standard Deviation 1.9082
|
-0.9485 ng/mL
Standard Deviation 2.3281
|
0.3436 ng/mL
Standard Deviation 1.2855
|
3.1418 ng/mL
Standard Deviation 11.7555
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 281
|
-0.5640 ng/mL
Standard Deviation 1.7835
|
-0.4729 ng/mL
Standard Deviation 1.7693
|
-0.9485 ng/mL
Standard Deviation 2.3281
|
-0.0343 ng/mL
Standard Deviation 0.1283
|
0 ng/mL
Standard Deviation 0
|
|
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Change at Day 309
|
-0.5720 ng/mL
Standard Deviation 1.8088
|
-0.7833 ng/mL
Standard Deviation 2.7135
|
-0.9485 ng/mL
Standard Deviation 2.3281
|
-0.5654 ng/mL
Standard Deviation 2.1154
|
0 ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 309 Day 1 (Baseline) up to Day 309 (± 7 days)Population: Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received. Participants who received active study drug.
ADA positive at any time: observed at least once during the study (baseline included). Treatment-emergent ADA: ADA positive post-baseline only or boosted pre-existing ADA during the study period. Persistent positive: treatment-induced ADA positive at ≥ 2 post-baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive: treatment-induced ADA post-baseline positive but does not fulfill the criteria of persistent positive.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=13 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=18 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=17 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
ADA positive at any time
|
38.5 percentage of participants
|
28.6 percentage of participants
|
—
|
44.4 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
Baseline ADA positive
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
Baseline only ADA positive
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
Post-baseline ADA positive
|
38.5 percentage of participants
|
28.6 percentage of participants
|
—
|
44.4 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
Treatment-emergent ADA
|
38.5 percentage of participants
|
28.6 percentage of participants
|
—
|
44.4 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
Persistent positive
|
0 percentage of participants
|
0 percentage of participants
|
—
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
Transient positive
|
38.5 percentage of participants
|
28.6 percentage of participants
|
—
|
33.3 percentage of participants
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Day 113Population: Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized. Participants with an assessment at given time point by group.
Excluding data after rescue. Adjusted geometric mean ratio to baseline (90% CI) results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model. Ratios less than 1 indicate a decrease.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=15 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=14 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=15 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 113 in Anti-Citrullinated Protein Antibodies (ACPAs)
|
0.82 ratio
Interval 0.62 to 1.07
|
0.84 ratio
Interval 0.63 to 1.11
|
0.62 ratio
Interval 0.47 to 0.82
|
1.08 ratio
Interval 0.83 to 1.42
|
0.69 ratio
Interval 0.52 to 0.91
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Day 113Population: Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized. Participants with an assessment at given time point by group.
Excluding data after rescue. Adjusted geometric mean ratio to baseline (90% CI) results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model. Ratios less than 1 indicate a decrease.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=15 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=14 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=15 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=14 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 113 in Rheumatoid Factor (RF)
|
0.74 ratio
Interval 0.64 to 0.86
|
0.72 ratio
Interval 0.62 to 0.84
|
0.57 ratio
Interval 0.49 to 0.66
|
1.20 ratio
Interval 1.04 to 1.39
|
0.77 ratio
Interval 0.66 to 0.89
|
SECONDARY outcome
Timeframe: Day 113Population: Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized. Participants with an assessment at given time point by group.
Clinical remission is defined as DAS28-CRP \< 2.6. The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=16 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=15 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=16 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Remission at Day 113
|
6.3 percentage of participants
|
13.3 percentage of participants
|
13.3 percentage of participants
|
18.8 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) up to Day 309 (± 7 days)Population: Full Analysis Set: all randomized participants who received any dose of study drug, analyzed according to the treatment randomized. Participants who received rescue medication.
Based on Kaplan-Meier method.
Outcome measures
| Measure |
VIB4920 1500 mg Twice
n=16 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=15 Participants
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=15 Participants
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
Placebo
n=16 Participants
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=16 Participants
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Time to Start of New Treatment for Rheumatoid Arthritis (Rescue Medication)
|
NA days
Not calculable due to small number of participants rescued.
|
NA days
Not calculable due to small number of participants rescued.
|
NA days
Interval 196.0 to
Not calculable due to small number of participants rescued.
|
NA days
Not calculable due to small number of participants rescued.
|
NA days
Not calculable due to small number of participants rescued.
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
VIB4920 3000 mg Once
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
VIB4920 1500 mg Twice
Serious events: 1 serious events
Other events: 14 other events
Deaths: 1 deaths
VIB4920 3000 mg Twice
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
VIB4920 1500 mg 4 Times
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=16 participants at risk
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=18 participants at risk
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
VIB4920 1500 mg Twice
n=17 participants at risk
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=13 participants at risk
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=14 participants at risk
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
|---|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Participants received IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
VIB4920 3000 mg Once
n=18 participants at risk
Participants received IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
VIB4920 1500 mg Twice
n=17 participants at risk
Participants received IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 3000 mg Twice
n=13 participants at risk
Participants received IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
VIB4920 1500 mg 4 Times
n=14 participants at risk
Participants received IV infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
23.1%
3/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis postmenopausal
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
17.6%
3/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
15.4%
2/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliac joint dysfunction
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
11.1%
2/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
11.8%
2/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Nervous system disorders
Parkinsonian rest tremor
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
11.1%
2/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
11.8%
2/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Eye disorders
Cataract
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
COVID-19
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
17.6%
3/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
21.4%
3/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Cystitis
|
12.5%
2/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
15.4%
2/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
23.1%
3/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Injury, poisoning and procedural complications
Post vaccination syndrome
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.6%
1/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
11.8%
2/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
11.8%
2/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.7%
1/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Blood pressure increased
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
7.1%
1/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Body temperature increased
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Heart sounds abnormal
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Hepatic enzyme increased
|
6.2%
1/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
|
Investigations
SARS-CoV-2 antibody test positive
|
0.00%
0/16 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/18 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
5.9%
1/17 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/13 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
0.00%
0/14 • From screening (all cause mortality) or first dose of study drug (adverse events) through through Day 309 ± 7 days.
Safety analysis set: all participants who received any dose of study drug, analyzed according to the treatment that they actually received.
|
Additional Information
Ilias Alevizos, PhD, DMD
Horizon Therapeutics USA, Inc.
Phone: 866-479-6742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Horizon requests that any investigator/institution that plans on presenting/publishing results provide written notification of their request 60 days prior to their presentation/publication. Horizon requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Horizon needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER