Trial Outcomes & Findings for Trial of Verapamil in Chronic Rhinosinusitis (NCT NCT02454608)
NCT ID: NCT02454608
Last Updated: 2018-06-14
Results Overview
Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
baseline to week 8
Results posted on
2018-06-14
Participant Flow
Participant milestones
| Measure |
Treatment
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
Open Label
Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
|
|---|---|---|---|
|
Double-Blind Period
STARTED
|
15
|
14
|
0
|
|
Double-Blind Period
COMPLETED
|
15
|
12
|
0
|
|
Double-Blind Period
NOT COMPLETED
|
0
|
2
|
0
|
|
Open Label Period
STARTED
|
0
|
0
|
29
|
|
Open Label Period
COMPLETED
|
0
|
0
|
10
|
|
Open Label Period
NOT COMPLETED
|
0
|
0
|
19
|
Reasons for withdrawal
| Measure |
Treatment
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
Open Label
Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
|
|---|---|---|---|
|
Double-Blind Period
Lack of Efficacy
|
0
|
2
|
0
|
|
Open Label Period
Lost to Follow-up
|
0
|
0
|
11
|
|
Open Label Period
Withdrawal by Subject
|
0
|
0
|
8
|
Baseline Characteristics
Trial of Verapamil in Chronic Rhinosinusitis
Baseline characteristics by cohort
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
Open Label
n=29 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
29 participants
n=5 Participants
|
49 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline to week 8Population: Intention-to-treat analysis
Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome
Outcome measures
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)
|
-27.3 units on a scale
Standard Error 7.52
|
0.4 units on a scale
Standard Error 7.52
|
PRIMARY outcome
Timeframe: baseline to week 8Population: Intention-to-treat analysis
Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.
Outcome measures
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)
|
-44.03 units on a scale
Standard Error 7.66
|
-6.07 units on a scale
Standard Error 7.66
|
PRIMARY outcome
Timeframe: baseline to week 56Population: Intention-to-treat analysis
Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome
Outcome measures
| Measure |
Treatment
n=29 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)
Medicine Completers, baseline
|
31.8 units on a scale
Standard Error 5.24
|
—
|
|
Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)
Medicine Completers, week 56
|
24.14 units on a scale
Standard Error 6.17
|
—
|
|
Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)
Surgical Completers, baseline
|
72.00 units on a scale
Standard Error 4.58
|
—
|
|
Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)
Surgical Completers, week 12
|
8.00 units on a scale
Standard Error 2.08
|
—
|
PRIMARY outcome
Timeframe: baseline to week 56Population: Intention-to-treat analysis
Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.
Outcome measures
| Measure |
Treatment
n=29 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)
Medicine Completers, baseline
|
64.3 units on a scale
Standard Error 7.5
|
—
|
|
Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)
Medicine Completers, week 56
|
35.0 units on a scale
Standard Error 9.2
|
—
|
|
Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)
Surgical Completers, baseline
|
90.0 units on a scale
Standard Error 5.8
|
—
|
|
Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)
Surgical Completers, week 12
|
16.7 units on a scale
Standard Error 6.7
|
—
|
SECONDARY outcome
Timeframe: baseline to week 8Population: Intention-to-treat analysis
Minimum Score: 0 Maximum Score: 12 Higher value represents worse outcome.
Outcome measures
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Objective Sinonasal Symptoms on Lund-Kennedy Score(LKS)
|
-1.3 units on a scale
Standard Error 0.63
|
-0.25 units on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Week 8Population: Intention-to-treat analysis
Minimum Score: 0 Maximum Score: 24 Higher value represents worse outcome.
Outcome measures
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Objective Sinonasal Symptoms on Lund-McKay Score(LMS)
|
12.5 units on a scale
Standard Deviation 4.4
|
17.7 units on a scale
Standard Deviation 4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Mean change between baseline and week 8 measurements.Outcome measures
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Heart Rate
|
-1.4 beats per minute
Standard Deviation 9.16
|
4 beats per minute
Standard Deviation 30.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Mean change between baseline and week 8 measurementsOutcome measures
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Systolic Blood Pressure
|
-4.5 mmHg
Standard Deviation 13.2
|
-6.6 mmHg
Standard Deviation 19.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Mean change between baseline and week 8 measurementsOutcome measures
| Measure |
Treatment
n=10 Participants
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 Participants
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
|---|---|---|
|
Diastolic Blood Pressure
|
-0.6 mmHg
Standard Deviation 10.26
|
1 mmHg
Standard Deviation 7.85
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Open Label
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=10 participants at risk
Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
Control
n=10 participants at risk
Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
|
Open Label
n=29 participants at risk
Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
|
|---|---|---|---|
|
General disorders
Acute Sinusitis
|
30.0%
3/10 • Number of events 3 • 1 year
|
40.0%
4/10 • Number of events 4 • 1 year
|
0.00%
0/29 • 1 year
|
|
Ear and labyrinth disorders
Dizziness
|
40.0%
4/10 • Number of events 4 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
General disorders
Swelling of Hands or Feet
|
30.0%
3/10 • Number of events 3 • 1 year
|
0.00%
0/10 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Cardiac disorders
Slow, Fast or Irregular Heart Rate
|
20.0%
2/10 • Number of events 2 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
6.9%
2/29 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
60.0%
6/10 • Number of events 6 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
27.6%
8/29 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Heartburn
|
20.0%
2/10 • Number of events 2 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
17.2%
5/29 • Number of events 6 • 1 year
|
|
General disorders
Lightheadedness
|
50.0%
5/10 • Number of events 5 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
General disorders
Headache
|
30.0%
3/10 • Number of events 3 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
20.7%
6/29 • Number of events 6 • 1 year
|
|
General disorders
Fainting
|
0.00%
0/10 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/29 • 1 year
|
|
General disorders
Blurred Vision
|
20.0%
2/10 • Number of events 2 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/29 • 1 year
|
|
General disorders
Nausea
|
30.0%
3/10 • Number of events 3 • 1 year
|
0.00%
0/10 • 1 year
|
10.3%
3/29 • Number of events 3 • 1 year
|
|
General disorders
Tiredness
|
50.0%
5/10 • Number of events 5 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
20.7%
6/29 • Number of events 6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • 1 year
|
0.00%
0/10 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
Yellow Eyes or Skin
|
0.00%
0/10 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/29 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place