Trial Outcomes & Findings for Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement (NCT NCT01198873)
NCT ID: NCT01198873
Last Updated: 2013-02-12
Results Overview
Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
76 participants
Primary outcome timeframe
baseline (before randomization) and post-baseline (after 3-12 months of treatment)
Results posted on
2013-02-12
Participant Flow
Recruitment initiated in September 2010 was discontinued in September, 2011 due to significantly lower than planned enrollment with no feasibility to complete the trial within reasonable, meaningful timelines. At that time 57 sites in US and Canada had screened at least one patient.
After signature of the informed consent and after eligibility was confirmed, group assignment was made at site in a 1:1 ratio using a treatment code list generated centrally by Sanofi. Participants were considered as randomized as soon as the assignment was made. A total of 76 participants were randomized at 39 sites.
Participant milestones
| Measure |
Placebo
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
35
|
|
Overall Study
Treated
|
41
|
35
|
|
Overall Study
Evaluable for Efficacy
|
33
|
26
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
37
|
32
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
7
|
|
Overall Study
Study closure
|
29
|
23
|
|
Overall Study
Other than above
|
4
|
2
|
Baseline Characteristics
Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=35 Participants
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
74.1 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
72.0 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (before randomization) and post-baseline (after 3-12 months of treatment)Population: The analysis included all randomized and treated participants with at least one post-baseline echocardiographic assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis). The quality of the post-baseline echocardiography was inadequate for determining LAVi in one participant.
Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=26 Participants
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Change From Baseline in Left Atrial Volume Index (LAVi)
Baseline (n =33, 26)
|
37.555 mililiters/m2
Standard Deviation 5.899
|
37.715 mililiters/m2
Standard Deviation 6.597
|
|
Change From Baseline in Left Atrial Volume Index (LAVi)
Post-baseline (n =32, 26)
|
29.191 mililiters/m2
Standard Deviation 5.994
|
30.823 mililiters/m2
Standard Deviation 5.364
|
|
Change From Baseline in Left Atrial Volume Index (LAVi)
Change from baseline (n =32, 26)
|
-8.438 mililiters/m2
Standard Deviation 4.743
|
-6.892 mililiters/m2
Standard Deviation 5.759
|
SECONDARY outcome
Timeframe: baseline (before randomization) and post-baseline (after 3-12 months of treatment)Population: Modified intent-to-treat population as previously defined
left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=26 Participants
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Changes From Baseline in Left Atrial Function
LA conduit volume (n =29, 25)
|
-1.366 mililiters
Standard Deviation 5.652
|
-0.764 mililiters
Standard Deviation 5.759
|
|
Changes From Baseline in Left Atrial Function
LA passive emptying fraction (n = 19, 19)
|
-0.074 mililiters
Standard Deviation 0.074
|
-0.019 mililiters
Standard Deviation 0.117
|
|
Changes From Baseline in Left Atrial Function
LA active emptying fraction (n = 19, 19)
|
0.057 mililiters
Standard Deviation 0.104
|
0.067 mililiters
Standard Deviation 0.105
|
|
Changes From Baseline in Left Atrial Function
LA passive emptying volume (n = 19, 19)
|
-10.783 mililiters
Standard Deviation 7.798
|
-4.566 mililiters
Standard Deviation 9.094
|
|
Changes From Baseline in Left Atrial Function
LA active emptying volume (n = 19, 19)
|
-0.052 mililiters
Standard Deviation 4.707
|
1.198 mililiters
Standard Deviation 5.695
|
SECONDARY outcome
Timeframe: baseline (before randomization) and post-baseline (after 3-12 months of treatment)Population: Modified intent-to-treat population as previously defined
Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=26 Participants
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Changes From Baseline in Left Atrial Dimension
|
-0.124 centimeters
Standard Deviation 0.188
|
-0.166 centimeters
Standard Deviation 0.161
|
SECONDARY outcome
Timeframe: baseline (before randomization) and post-baseline (after 3-12 months of treatment)Population: Modified intent-to-treat population as previously defined
Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=26 Participants
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)
|
0.948 percentage of blood pumped out
Standard Deviation 3.333
|
1.147 percentage of blood pumped out
Standard Deviation 3.997
|
SECONDARY outcome
Timeframe: baseline (before randomization) and post-baseline (after 3-12 months of treatment)left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=26 Participants
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Changes From Baseline in Left Ventricular Function
Mitral annular velocity (E')
|
0.847 centimeters/second
Standard Deviation 2.002
|
-0.119 centimeters/second
Standard Deviation 1.845
|
|
Changes From Baseline in Left Ventricular Function
Peak early diastolic transmitral flow velocity (E)
|
5.165 centimeters/second
Standard Deviation 15.440
|
-10.497 centimeters/second
Standard Deviation 27.890
|
|
Changes From Baseline in Left Ventricular Function
Peak late diastolic transmitral flow velocity (A)
|
0.076 centimeters/second
Standard Deviation 11.674
|
4.319 centimeters/second
Standard Deviation 14.275
|
|
Changes From Baseline in Left Ventricular Function
E/E' ratio
|
-0.787 centimeters/second
Standard Deviation 3.346
|
-1.443 centimeters/second
Standard Deviation 4.288
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Dronedarone
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=35 participants at risk
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Cardiac disorders
Angina pectoris
|
2.4%
1/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
0.00%
0/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
0.00%
0/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
General disorders
Asthenia
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
2.9%
1/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
|
Dronedarone
n=35 participants at risk
Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
5.7%
2/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
5.7%
2/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
8.6%
3/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
5.7%
2/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
8.6%
3/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Vascular disorders
Hypertension
|
7.3%
3/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
0.00%
0/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
11.4%
4/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
8.6%
3/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
5.7%
2/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
5.7%
2/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
General disorders
Fatigue
|
2.4%
1/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
11.4%
4/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
|
General disorders
Oedema peripheral
|
4.9%
2/41 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
|
5.7%
2/35 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug in the period spanning from signature of the Informed Consent Form up to the last visit.
The analysis included all randomized participants who received at least one dose of study drug and all AE that developed or worsened from randomization up to 10 days after last study drug intake. Participants were considered according to the treatment actually received regardless the amount of treatment administered.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months after trial completion, the Investigator can present or publish trial results. A copy is submitted to the Sponsor for review and comment at least 30 days in advance of any presentation or submission for publication. The Sponsor can require to delay the communication for a period not exceeding 90 days to allow for filing a patent application or such other measures as Sponsor deems appropriate to establish and preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER