Trial Outcomes & Findings for Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD) (NCT NCT05046795)
NCT ID: NCT05046795
Last Updated: 2024-11-01
Results Overview
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
258 participants
Primary outcome timeframe
Baseline and Day 85
Results posted on
2024-11-01
Participant Flow
258 subjects were randomized, of which 257 received randomized study treatment. The one subject who was not treated was randomized in error
Participant milestones
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
128
|
|
Overall Study
COMPLETED
|
107
|
99
|
|
Overall Study
NOT COMPLETED
|
22
|
29
|
Reasons for withdrawal
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
15
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Public health emergency (COVID-19) restrictions
|
2
|
3
|
Baseline Characteristics
Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD)
Baseline characteristics by cohort
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=129 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=128 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 Years
STANDARD_DEVIATION 6.18 • n=5 Participants
|
67.7 Years
STANDARD_DEVIATION 6.80 • n=7 Participants
|
67.6 Years
STANDARD_DEVIATION 6.48 • n=5 Participants
|
|
Age, Customized
Age group · <65 years
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Customized
Age group · >=65 years
|
93 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian - Chinese
|
129 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian - Not Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
129 participants
n=5 Participants
|
128 participants
n=7 Participants
|
257 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
22.92 kg/m^2
STANDARD_DEVIATION 3.559 • n=5 Participants
|
23.44 kg/m^2
STANDARD_DEVIATION 3.106 • n=7 Participants
|
23.18 kg/m^2
STANDARD_DEVIATION 3.345 • n=5 Participants
|
|
Concomitant inhaled corticosteroid use
Yes
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Concomitant inhaled corticosteroid use
No
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Concomitant long acting beta agonist use
Yes
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Concomitant long acting beta agonist use
No
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Reversibility to ipratropium
Yes
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Reversibility to ipratropium
No
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 85Population: The Analysis Population was all subjects in the Full Analysis Set who had evaluable data for the respective endpoint. Missing data was not imputed.
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Outcome measures
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=105 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=99 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Trough FEV1 on Day 85
|
55.12 mL
Standard Error 23.974
|
-95.78 mL
Standard Error 24.504
|
PRIMARY outcome
Timeframe: Baseline, Day 29, Day 57 and Day 85Population: Full analysis set (missing data for Day 85 was imputed from Day 29 or Day 57 data by Last Observation Carried Forward)
Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward
Outcome measures
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=129 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=128 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Trough FEV1 on Day 85 - Sensitivity Analysis With Missing Data Imputed
|
52.05 mL
Standard Error 27.036
|
-92.30 mL
Standard Error 27.502
|
SECONDARY outcome
Timeframe: Baseline and Day 85Population: The Analysis Population was all subjects in the Full Analysis Set who had evaluable data for the respective endpoint. Missing data was not imputed.
Change from baseline (Day 1, pre-dose) trough Forced Vital Capacity (FVC) on Day 85
Outcome measures
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=105 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=99 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Trough FVC on Day 85
|
97.92 mL
Standard Error 41.833
|
-189.83 mL
Standard Error 42.801
|
SECONDARY outcome
Timeframe: Day 1, from 45 minutes before dosing to 2 hours after dosingPopulation: Full analysis set
Baseline FEV1 was defined as the average of the -45 and -15 minute measurements prior to dosing of study drug on Day 1. Peak FEV1 (0-2h) was defined as the highest post dose FEV1 value within 2 hours after the dosing.
Outcome measures
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=129 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=128 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Change From Baseline in Peak FEV1 (0-2h) on Day 1
|
234.2 mL
Standard Error 21.55
|
128.4 mL
Standard Error 21.92
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 85, from 45 minutes before dosing to 2 hours after dosingPopulation: The Analysis Population was all subjects in the Full Analysis Set who had evaluable data for the respective endpoint. Missing data was not imputed.
Baseline FEV1 was defined as the average of the -45 and -15 minute measurements prior to dosing of study drug on Day 1. Peak FEV1 (0-2h) was defined as the highest post dose FEV1 value within 2 hours after the dosing.
Outcome measures
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=103 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=97 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Change From Baseline in Peak FEV1 (0-2h) on Day 85
|
199.0 mL
Standard Error 32.72
|
44.2 mL
Standard Error 33.62
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 85Population: The Analysis Population was all subjects in the Full Analysis Set who had evaluable data for the respective endpoint. Missing data was not imputed.
Change from Baseline in the St George's Respiratory Questionnaire (SGRQ) Total Score on Day 85. Scores range from 0 to 100, with higher scores indicating more health limitations. A reduction of 4 or more points is considered to be a clinically meaningful improvement
Outcome measures
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=110 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=112 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Change From Baseline in SGRQ Total Score on Day 85
|
-4.8 Score on a scale
Standard Error 2.17
|
0.2 Score on a scale
Standard Error 2.20
|
SECONDARY outcome
Timeframe: Day 85Population: The Analysis Population was all subjects in the Full Analysis Set who had evaluable data for the respective endpoint. Missing data was not imputed.
Number of subjects with a decrease from baseline of ≥4 units in SGRQ total score (which was defined as a responder) on Day 85
Outcome measures
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=110 Participants
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=112 Participants
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Number (%) of SGRQ Responders on Day 85
|
58 Participants
|
45 Participants
|
Adverse Events
Revefenacin Inhalation Solution 175 mcg QD.
Serious events: 14 serious events
Other events: 58 other events
Deaths: 1 deaths
Placebo Inhalation Solution QD.
Serious events: 11 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=129 participants at risk
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=128 participants at risk
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
3.9%
5/129 • Number of events 5 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
3.9%
5/128 • Number of events 5 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Pneumonia
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Febrile infection
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
COVID-19
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
HIV infection
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Cerebral infarction
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Transient ischaemic attack
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Congenital, familial and genetic disorders
Postauricular fistula
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chest wall tumour
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
Other adverse events
| Measure |
Revefenacin Inhalation Solution 175 mcg QD.
n=129 participants at risk
Revefenacin inhalation solution 175 mcg in 3 mL administered once daily by nebulizer for 12 weeks
|
Placebo Inhalation Solution QD.
n=128 participants at risk
Placebo inhalation solution in 3 mL administered once daily by nebulizer for 12 weeks
|
|---|---|---|
|
Infections and infestations
COVID-19
|
9.3%
12/129 • Number of events 12 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
6.2%
8/128 • Number of events 8 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Pneumonia
|
3.9%
5/129 • Number of events 5 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
2.3%
3/128 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Coronavirus infection
|
3.1%
4/129 • Number of events 4 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
3/129 • Number of events 4 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
8.6%
11/128 • Number of events 13 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Asymptomatic bacteriuria
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Sinusitis
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
9.3%
12/129 • Number of events 12 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
11.7%
15/128 • Number of events 15 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.4%
7/129 • Number of events 7 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
3.1%
4/128 • Number of events 5 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
3/129 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
3.1%
4/128 • Number of events 4 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
General disorders
Chest discomfort
|
6.2%
8/129 • Number of events 9 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
3.9%
5/128 • Number of events 5 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
General disorders
Pyrexia
|
3.1%
4/129 • Number of events 4 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
4/129 • Number of events 4 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
3.1%
4/128 • Number of events 4 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
Gallbladder polyp
|
2.3%
3/129 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.3%
3/129 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Toothache
|
2.3%
3/129 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.78%
1/128 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
2.3%
3/128 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
2.3%
3/128 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
3/129 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Cardiac failure
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Eye disorders
Asthenopia
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
0.00%
0/128 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Dizziness
|
1.6%
2/129 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Renal cyst
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Vascular disorders
Hypertension
|
0.78%
1/129 • Number of events 1 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
2.3%
3/128 • Number of events 3 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/129 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
1.6%
2/128 • Number of events 2 • 12 week treatment period and for up to 30 days after the last dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication by an Institution/Investigator of the study results shall not be made before the first multi-center publication by the Sponsor. Thereafter, before submission for publication or presentation, the Investigator shall allow the Sponsor at least 60 days to review any manuscript and at least 30 days to review any poster presentation, abstract or other written or oral material. The Sponsor may request in writing that any publication or presentation be withheld for a further 60 days.
- Publication restrictions are in place
Restriction type: OTHER