Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype (NCT NCT04474197)
NCT ID: NCT04474197
Last Updated: 2022-05-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
From Baseline at Day 28
Results posted on
2022-05-26
Participant Flow
This study was conducted in participants 18 through 80 of years of age, inclusive with the PiZZ genotype.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
Participants received VX-864 100 milligrams (mg) every 12 hours (q12h) in the treatment period for 28 days.
|
VX-864 300 mg
Participants received VX-864 300 mg q12h in the treatment period for 28 days.
|
VX-864 500 mg
Participants received VX-864 500 mg q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
9
|
18
|
|
Overall Study
COMPLETED
|
7
|
9
|
9
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
Participants received VX-864 100 milligrams (mg) every 12 hours (q12h) in the treatment period for 28 days.
|
VX-864 300 mg
Participants received VX-864 300 mg q12h in the treatment period for 28 days.
|
VX-864 500 mg
Participants received VX-864 500 mg q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal of consent (not due to adverse event)
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
n=10 Participants
Participants received VX-864 100 mg q12h in the treatment period for 28 days.
|
VX-864 300 mg
n=9 Participants
Participants received VX-864 300 mg q12h in the treatment period for 28 days.
|
VX-864 500 mg
n=18 Participants
Participants received VX-864 500 mg q12h in the treatment period for 28 days.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (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
|
|
Plasma Functional Alpha-1 Antitrypsin (AAT) Levels
|
4.7 micromole per liter
STANDARD_DEVIATION 1.3 • n=5 Participants
|
4.0 micromole per liter
STANDARD_DEVIATION 0.7 • n=7 Participants
|
3.8 micromole per liter
STANDARD_DEVIATION 0.9 • n=5 Participants
|
4.1 micromole per liter
STANDARD_DEVIATION 0.6 • n=4 Participants
|
4.1 micromole per liter
STANDARD_DEVIATION 0.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: From Baseline at Day 28Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
n=10 Participants
Participants received VX-864 100 mg q12h in the treatment period for 28 days.
|
VX-864 300 mg
n=9 Participants
Participants received VX-864 300 mg dose q12h in the treatment period for 28 days.
|
VX-864 500 mg
n=18 Participants
Participants received VX-864 500 mg dose q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
Change in Plasma Functional Alpha-1 Antitrypsin (AAT) Levels
|
-0.1 micromole per liter
Standard Error 0.3
|
2.3 micromole per liter
Standard Error 0.3
|
2.3 micromole per liter
Standard Error 0.2
|
2.1 micromole per liter
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Day 1 up to Week 8Population: The safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
n=10 Participants
Participants received VX-864 100 mg q12h in the treatment period for 28 days.
|
VX-864 300 mg
n=9 Participants
Participants received VX-864 300 mg dose q12h in the treatment period for 28 days.
|
VX-864 500 mg
n=18 Participants
Participants received VX-864 500 mg dose q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants With AEs
|
4 participants
|
7 participants
|
7 participants
|
17 participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants With SAEs
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From Baseline at Day 28Population: FAS.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
n=10 Participants
Participants received VX-864 100 mg q12h in the treatment period for 28 days.
|
VX-864 300 mg
n=9 Participants
Participants received VX-864 300 mg dose q12h in the treatment period for 28 days.
|
VX-864 500 mg
n=18 Participants
Participants received VX-864 500 mg dose q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
Change in Plasma Antigenic AAT Levels
|
-0.1 micromole per liter
Standard Error 0.4
|
3.4 micromole per liter
Standard Error 0.4
|
2.9 micromole per liter
Standard Error 0.4
|
2.6 micromole per liter
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Pre-dose at Day 7, Day 14, Day 21 and Day 28Population: Pharmacokinetic (PK) set included participants who received at least 1 dose of study drug. Here "Number analyzed" signifies those participants who were evaluable for this endpoint at specified time points.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
n=9 Participants
Participants received VX-864 100 mg q12h in the treatment period for 28 days.
|
VX-864 300 mg
n=18 Participants
Participants received VX-864 300 mg dose q12h in the treatment period for 28 days.
|
VX-864 500 mg
Participants received VX-864 500 mg dose q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
Observed Pre-dose Plasma Concentration (Ctrough) of VX-864
Day 7
|
1.13 microgram per milliliter
Standard Deviation 0.743
|
1.62 microgram per milliliter
Standard Deviation 0.665
|
2.74 microgram per milliliter
Standard Deviation 2.89
|
—
|
|
Observed Pre-dose Plasma Concentration (Ctrough) of VX-864
Day 14
|
0.852 microgram per milliliter
Standard Deviation 0.340
|
1.47 microgram per milliliter
Standard Deviation 0.847
|
4.35 microgram per milliliter
Standard Deviation 5.36
|
—
|
|
Observed Pre-dose Plasma Concentration (Ctrough) of VX-864
Day 21
|
0.868 microgram per milliliter
Standard Deviation 0.503
|
1.21 microgram per milliliter
Standard Deviation 0.770
|
1.79 microgram per milliliter
Standard Deviation 0.922
|
—
|
|
Observed Pre-dose Plasma Concentration (Ctrough) of VX-864
Day 28
|
0.797 microgram per milliliter
Standard Deviation 0.327
|
1.29 microgram per milliliter
Standard Deviation 0.646
|
2.55 microgram per milliliter
Standard Deviation 2.40
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
VX-864 100 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VX-864 300 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VX-864 500 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=7 participants at risk
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
n=10 participants at risk
Participants received VX-864 100 mg q12h in the treatment period for 28 days.
|
VX-864 300 mg
n=9 participants at risk
Participants received VX-864 300 mg q12h in the treatment period for 28 days.
|
VX-864 500 mg
n=18 participants at risk
Participants received VX-864 500 mg q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Participants received placebo matched to VX-864 in the treatment period for 28 days.
|
VX-864 100 mg
n=10 participants at risk
Participants received VX-864 100 mg q12h in the treatment period for 28 days.
|
VX-864 300 mg
n=9 participants at risk
Participants received VX-864 300 mg q12h in the treatment period for 28 days.
|
VX-864 500 mg
n=18 participants at risk
Participants received VX-864 500 mg q12h in the treatment period for 28 days.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Eye disorders
Eye allergy
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Eye disorders
Macular degeneration
|
14.3%
1/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
11.1%
2/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
22.2%
4/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
22.2%
2/9 • Day 1 up to Week 8
|
22.2%
4/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
General disorders
Asthenia
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
General disorders
Chills
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
General disorders
Fatigue
|
0.00%
0/7 • Day 1 up to Week 8
|
20.0%
2/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
16.7%
3/18 • Day 1 up to Week 8
|
|
General disorders
Feeling abnormal
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
General disorders
Feeling cold
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
General disorders
Malaise
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Day 1 up to Week 8
|
20.0%
2/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Investigations
Blood cholesterol increased
|
14.3%
1/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
Blood potassium decreased
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
Haemoglobin increased
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
Low density lipoprotein increased
|
14.3%
1/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Investigations
Protein total decreased
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
Red blood cell count increased
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Investigations
White blood cells urine positive
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
22.2%
2/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
22.2%
2/9 • Day 1 up to Week 8
|
11.1%
2/18 • Day 1 up to Week 8
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Day 1 up to Week 8
|
20.0%
2/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
11.1%
1/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Skin and subcutaneous tissue disorders
Polymorphic light eruption
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
5.6%
1/18 • Day 1 up to Week 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Day 1 up to Week 8
|
10.0%
1/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
0.00%
0/18 • Day 1 up to Week 8
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Day 1 up to Week 8
|
0.00%
0/10 • Day 1 up to Week 8
|
0.00%
0/9 • Day 1 up to Week 8
|
11.1%
2/18 • Day 1 up to Week 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place