Trial Outcomes & Findings for A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD (NCT NCT02643082)
NCT ID: NCT02643082
Last Updated: 2019-03-19
Results Overview
Specific image-based airway volume. Average across lobe, adjusted for lobe volume
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Day 15
Results posted on
2019-03-19
Participant Flow
This study was conducted at 1 site in Antwerp Belgium from January 2016 to December 2016.The study was anticipated to run for approximately 9 months but not to expected to exceed 12 months. The study period was duration was expected to run approximately 13 weeks for each subject.
Subjects were randomized into 1 of 2 treatment sequences: subjects in Sequence 1 received GFF MDI in Treatment Period 1 followed by Placebo MDI in Treatment Period 2, and subjects in Sequence 2 received Placebo MDI in Treatment Period 1 followed by GFF MDI in Treatment Period 2. There was a a washout of 5-21 days,in between treatment periods.
Participant milestones
| Measure |
GFF MDI/Placebo MDI
Treatment Sequence of Glycopyrronium Formoterol Fumarate Metered Dose Inhalation/Placebo Metered Dose Inhalation
|
Placebo MDI/GFF MDI
Treatment Sequence of Placebo Metered Dose Inhalation/Glycopyrronium Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
|
Period 1
COMPLETED
|
9
|
10
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Washout
STARTED
|
9
|
10
|
|
Washout
COMPLETED
|
9
|
10
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
9
|
10
|
|
Period 2
COMPLETED
|
9
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
GFF MDI/Placebo MDI
Treatment Sequence of Glycopyrronium Formoterol Fumarate Metered Dose Inhalation/Placebo Metered Dose Inhalation
|
Placebo MDI/GFF MDI
Treatment Sequence of Placebo Metered Dose Inhalation/Glycopyrronium Formoterol Fumarate Metered Dose Inhalation
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Baseline characteristics by cohort
| Measure |
Overall Study
n=20 Participants
All Randomized Patients
|
|---|---|
|
Age, Continuous
|
64.8 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: ITT Population
Specific image-based airway volume. Average across lobe, adjusted for lobe volume
Outcome measures
| Measure |
GFF MDI 14.4/9.6 µg
n=20 Participants
GFF MDI
|
Placebo MDI
n=19 Participants
Placebo
|
|---|---|---|
|
Specific Airway Volume (siVaw)
|
1.79 mL/L
Interval 1.48 to 2.16
|
1.02 mL/L
Interval 0.85 to 1.24
|
PRIMARY outcome
Timeframe: Day 15Population: ITT Population
Specific image-based airway resistance. Average across lobes, adjusted for lobe volume
Outcome measures
| Measure |
GFF MDI 14.4/9.6 µg
n=20 Participants
GFF MDI
|
Placebo MDI
n=19 Participants
Placebo
|
|---|---|---|
|
Specific Airway Resistance (siRaw)
|
0.09 kPa s
Interval 0.07 to 0.11
|
0.30 kPa s
Interval 0.23 to 0.4
|
SECONDARY outcome
Timeframe: Day 15Population: ITT Population
iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume
Outcome measures
| Measure |
GFF MDI 14.4/9.6 µg
n=20 Participants
GFF MDI
|
Placebo MDI
n=19 Participants
Placebo
|
|---|---|---|
|
Airway Resistance (iRaw)
|
0.07 kPa s/L
Interval 0.06 to 0.1
|
0.25 kPa s/L
Interval 0.19 to 0.33
|
SECONDARY outcome
Timeframe: Day 15Population: ITT Population
iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume
Outcome measures
| Measure |
GFF MDI 14.4/9.6 µg
n=20 Participants
GFF MDI
|
Placebo MDI
n=19 Participants
Placebo
|
|---|---|---|
|
Airway Volume (iVaw)
|
2.11 mL
Interval 1.73 to 2.58
|
1.18 mL
Interval 0.97 to 1.44
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT Population
Change from baseline in Forced Expiratory Volume at 1 second
Outcome measures
| Measure |
GFF MDI 14.4/9.6 µg
n=20 Participants
GFF MDI
|
Placebo MDI
n=19 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in FEV1 (L) at Day 15
|
0.334 Liters
Interval 0.245 to 0.422
|
-0.110 Liters
Interval -0.198 to -0.022
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: ITT Population
Change from baseline in Functional Residual Capacity
Outcome measures
| Measure |
GFF MDI 14.4/9.6 µg
n=20 Participants
GFF MDI
|
Placebo MDI
n=19 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in FRC (L) at Day 15
|
0.90 Liters
Interval 0.86 to 0.93
|
1.03 Liters
Interval 0.99 to 1.07
|
Adverse Events
Overall Study
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
GFF MDI 14.4/9.6 µg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo MDI
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall Study
n=20 participants at risk
All Randomized Patients
|
GFF MDI 14.4/9.6 µg
n=20 participants at risk
GFF MDI
|
Placebo MDI
n=19 participants at risk
Placebo
|
|---|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
Other adverse events
| Measure |
Overall Study
n=20 participants at risk
All Randomized Patients
|
GFF MDI 14.4/9.6 µg
n=20 participants at risk
GFF MDI
|
Placebo MDI
n=19 participants at risk
Placebo
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airway Disorder
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Nervous system disorders
Tremor
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Infections and infestations
Respiratory Tract Infection
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
General disorders
Oedema
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Metabolism and nutrition disorders
Iron Defficiency
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Renal and urinary disorders
Renal Mass
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Renal and urinary disorders
Renal Pain
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/20 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/19 • Adverse events were collected from the time the subject signed consent throughout the two treatment periods and washout period (approximately 49 days) and up to 10 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER