Trial Outcomes & Findings for Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence (NCT NCT04704050)
NCT ID: NCT04704050
Last Updated: 2025-10-30
Results Overview
Investigators monitored subjects upon discharge, 24-48 hours after AF ablation. This was recorded by either the occurrence of a single positive atrial arrhythmias (AA) ECG reading on a 12-lead ECG, Holter monitor, obtained on the daily event strips from the Preventice monitoring device, or 30-day monitoring patch.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Up to 56 weeks. From date of ablation until the date of first documented Atrial Fibrillation recurrence, whichever came first, assessed up to 56 weeks.
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Treatment Group
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
Baseline characteristics by cohort
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
64.50 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeks. From date of ablation until the date of first documented Atrial Fibrillation recurrence, whichever came first, assessed up to 56 weeks.Investigators monitored subjects upon discharge, 24-48 hours after AF ablation. This was recorded by either the occurrence of a single positive atrial arrhythmias (AA) ECG reading on a 12-lead ECG, Holter monitor, obtained on the daily event strips from the Preventice monitoring device, or 30-day monitoring patch.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Post-ablation Atrial Fibrillation Recurrence
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeks. From date of ablation until the date of first documented Atrial Fibrillation recurrence, whichever came first, assessed up to 56 weeks.New anti-arrhythmic drug (AAD) initiation for AF recurrence after AF ablation, including initiation of the treatment during the blanking period, or with no available positive ECG reading.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At baseline, at month 3, at month 12Atrial arrhythmia (AA) episodes associated with palpitations, chest pain, dyspnea, dizziness, syncope, or unusual fatigue and weakness were assessed using the Atrial Fibrillation Severity Scale (AFSS) questionnaire. The AFSS is a validated questionnaire designed to measure the burden of atrial arrhythmias, including atrial fibrillation and other irregular heart rhythms. The AA symptom burden score is derived from the AFSS summary score, which averages the frequency, duration, and patient-perceived severity of AA episodes. The AFSS symptom burden score ranges from 3 to 30, with higher scores indicating greater AA burden. Subscale scores (frequency, duration, and severity) are each rated on a scale of 1 to 10 and are averaged to calculate the total burden score. Patients completed the AFSS at baseline, 3 months, and 12 months. Reported data in the results table reflect the mean score at the 12-month time point.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Atrial Fibrillation Episodes
|
7.5 Scores on a scale
Standard Deviation 1.73
|
7.8 Scores on a scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: 1 yearWhether patients in either treatment arm require a repeat cardiac ablation.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Repeat Cardiac Ablation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearWhether patients in either treatment arm require cardioversion.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Cardioversion
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe percentage of time a patient is in atrial fibrillation during the monitoring period, 24-48 hours and, at 3 months and 12 months post-ablation. Burden will be recorded as a time-weighted average (%) based on data from wearable devices.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Atrial Fibrillation Burden
|
9 Percentage of time
Standard Deviation 4.55
|
4.5 Percentage of time
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: At baseline, at month 3, at month 12Quality of life (QoL) was assessed through the Atrial Fibrillation Severity Scale (AFSS), a validated instrument that evaluates the impact of AF across multiple domains, including symptom burden, health care utilization, and overall well-being. The Global Well-being domain of the AFSS is assessed using a single-item question (A4), which measures overall quality of life on a scale from 1 to 10, where higher scores indicate better quality of life. Patients completed the questionnaire at baseline, 3 months, and 12 months. The reported data in the results table reflect the mean score at the 12-month time point.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Quality of Life (Online Questionnaire Form)
|
8.8 Scores on a scale
Standard Deviation 1.30
|
10 Scores on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Through trial completion, up to 56 weeks.Assessment of adverse events related to treatment given. Evaluated at 3, 12 months visits and during 6 \& 9 month phone call visits.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Anemia
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Fatigue
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Hypoxemia
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Elevated creatinine
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Thrombocytopenia
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Dyspnea
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Dyspnea on effort
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Increased Troponin
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Intermittent Nausea
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Intermittent Headache
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Upset Stomach
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Right shoulder pain
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Right rotator cuff tear
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Elevated uric acid levels
|
0 Events
|
1 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Excessive flatulence
|
0 Events
|
1 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Hemorrhoids
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Prostate hyperplasia
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Hypertension
|
0 Events
|
1 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Worsening of Hyperlipidemia
|
0 Events
|
1 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Right lung mass
|
0 Events
|
1 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Increased shoulder pain
|
0 Events
|
1 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Leukocytosis
|
0 Events
|
1 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Nausea
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Diarrhea
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Rash on Chest
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Spinal Stenosis
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Urinary incontinence
|
1 Events
|
0 Events
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Erectile dysfunction
|
1 Events
|
0 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearRecords of any cardiac events requiring hospitalization.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Hospitalization
Anemia
|
1 Events
|
0 Events
|
|
Hospitalization
Chest Pain
|
0 Events
|
1 Events
|
|
Hospitalization
Dizziness
|
0 Events
|
1 Events
|
|
Hospitalization
Dyspnea
|
0 Events
|
1 Events
|
|
Hospitalization
Hematuria
|
0 Events
|
1 Events
|
|
Hospitalization
GERD
|
0 Events
|
1 Events
|
|
Hospitalization
Peripheral neuropathy
|
1 Events
|
0 Events
|
|
Hospitalization
Increased Troponin
|
1 Events
|
0 Events
|
|
Hospitalization
Right lower extremity swelling
|
0 Events
|
1 Events
|
|
Hospitalization
Left lower extremity swelling
|
0 Events
|
1 Events
|
|
Hospitalization
Left upper extremity swelling
|
0 Events
|
1 Events
|
|
Hospitalization
Acute gout flare-up
|
0 Events
|
1 Events
|
|
Hospitalization
Cellulitis
|
0 Events
|
1 Events
|
|
Hospitalization
Fluid Overload
|
0 Events
|
1 Events
|
|
Hospitalization
Acute Kidney Injury
|
0 Events
|
1 Events
|
|
Hospitalization
Acute Tubular Necrosis
|
0 Events
|
1 Events
|
|
Hospitalization
Hyperkalemia
|
0 Events
|
1 Events
|
|
Hospitalization
Hypotension
|
0 Events
|
1 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearRecords of mortality associated with cardiovascular events.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearRecords of stroke or TIA based on cardiac emboli.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 Participants
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Stroke/ Transient Ischemic Attacks (TIA)
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Group
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=12 participants at risk
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 participants at risk
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
16.7%
2/12 • Number of events 3 • 13 Months
|
30.0%
3/10 • Number of events 15 • 13 Months
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Nervous system disorders
Peripheral neuropathy
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Cardiac disorders
Increased Troponin
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Vascular disorders
Right lower extremity swelling
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Vascular disorders
Left lower extremity swelling
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Vascular disorders
Left upper extremity swelling
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Acute gout flare-up
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Fluid Overload
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Acute Tubular Necrosis
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
Other adverse events
| Measure |
Treatment Group
n=12 participants at risk
Dronedarone 400 mg orally, twice per day (BID)
dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.
|
Control Group
n=10 participants at risk
Placebo tablet orally, twice per day (BID)
Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Worsening of Hyperlipidemia
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Cardiac disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Cardiac disorders
Dyspnea on effort
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Renal and urinary disorders
Elevated Creatinine
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Renal and urinary disorders
Prostate hyperplasia
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Right lung mass
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Intermittent Nausea
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Gastrointestinal disorders
Upset Stomach
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Gastrointestinal disorders
Excessive flatulence
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Nervous system disorders
Intermittent Headache
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Nervous system disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Right rotator cuff tear
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Increased shoulder pain
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
Musculoskeletal and connective tissue disorders
Elevated uric acid levels
|
0.00%
0/12 • 13 Months
|
10.0%
1/10 • Number of events 1 • 13 Months
|
|
General disorders
Rash on Chest
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.3%
1/12 • Number of events 1 • 13 Months
|
0.00%
0/10 • 13 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place