Trial Outcomes & Findings for Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis (NCT NCT02024555)
NCT ID: NCT02024555
Last Updated: 2020-07-09
Results Overview
Change in percent predicted absolute forced vital capacity (FVC) in participants with pulmonary sarcoidosis, comparing baseline with performance after completion of 16 weeks of therapy. This will involve comparing sarcoidosis and placebo after 16 weeks of therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Baseline to 16 weeks
Results posted on
2020-07-09
Participant Flow
446 participants were screened but only 97 participants met inclusion/exclusion and were randomized.
Participant milestones
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
COMPLETED
|
43
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis
Baseline characteristics by cohort
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=49 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Weight
|
92.78 kilograms
STANDARD_DEVIATION 24.45 • n=5 Participants
|
97.54 kilograms
STANDARD_DEVIATION 21.99 • n=7 Participants
|
95.19 kilograms
STANDARD_DEVIATION 23.24 • n=5 Participants
|
|
Heart Rate
|
79.59 beats per minute
STANDARD_DEVIATION 17.7 • n=5 Participants
|
76.19 beats per minute
STANDARD_DEVIATION 11.66 • n=7 Participants
|
77.91 beats per minute
STANDARD_DEVIATION 13.33 • n=5 Participants
|
|
6 minute walk test
|
416.25 meters
STANDARD_DEVIATION 140.69 • n=5 Participants
|
416.49 meters
STANDARD_DEVIATION 105.16 • n=7 Participants
|
416.33 meters
STANDARD_DEVIATION 123.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 16 weeksPopulation: Only 43 participants in each arm completed this measure
Change in percent predicted absolute forced vital capacity (FVC) in participants with pulmonary sarcoidosis, comparing baseline with performance after completion of 16 weeks of therapy. This will involve comparing sarcoidosis and placebo after 16 weeks of therapy.
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=43 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=43 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Change in Percent Predicted Absolute Forced Vital Capacity (FVC) in Participants With Pulmonary Sarcoidosis, Comparing Baseline With Performance After Completion of 16 Weeks of Therapy.
|
0.35 percentage predicted absolute FVC
Standard Deviation 6.76
|
0.17 percentage predicted absolute FVC
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: The outcome was not completed due to lack of funds for radiology services.
Radiographic improvement in sarcoidosis lung disease by frontal chest x-ray . Local investigators will score chest x-rays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4, 8, and 16 and 24 weeksPopulation: Week 24 assessment was optional. Not all participants completed the 6 minute walk test.
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=48 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Six Minute Walk, Distance in Meters
Baseline
|
416.25 meters
Standard Error 140.69
|
416.41 meters
Standard Error 105.15
|
|
Six Minute Walk, Distance in Meters
Week 4
|
432.65 meters
Standard Error 155.5
|
428.35 meters
Standard Error 92.36
|
|
Six Minute Walk, Distance in Meters
Week 8
|
451.59 meters
Standard Error 146.12
|
420.21 meters
Standard Error 93.9
|
|
Six Minute Walk, Distance in Meters
Week 16
|
440.37 meters
Standard Error 137.08
|
430.85 meters
Standard Error 111.96
|
|
Six Minute Walk, Distance in Meters
Week 24
|
444.68 meters
Standard Error 165.09
|
425.18 meters
Standard Error 104.95
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, and 16 and 24 weeksPopulation: not all participants completed the measure and it was not recorded at week 24
measured using pulse oximetry
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=49 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Change in Oxygen Saturation
Baseline to week 4
|
0.39 percentage of oxygen saturation
Standard Deviation 3.33
|
-0.85 percentage of oxygen saturation
Standard Deviation 1.95
|
|
Change in Oxygen Saturation
Baseline to week 8
|
-0.12 percentage of oxygen saturation
Standard Deviation 2.95
|
-0.43 percentage of oxygen saturation
Standard Deviation 3.31
|
|
Change in Oxygen Saturation
Baseline to week 16
|
2.54 percentage of oxygen saturation
Standard Deviation 14.80
|
-0.46 percentage of oxygen saturation
Standard Deviation 3.79
|
SECONDARY outcome
Timeframe: Baseline, 4, 8 and 16 weeksPopulation: this measure was not administered
Outcome measure if a composite
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: questionnaire was only administered at baseline and 16 weeks and not all participants completed the questionnaire at week 16
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=41 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=39 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Change in the Saint George's Respiratory Questionnaire (SGRQ)
|
-2.23 score on a scale
Standard Error 11.9
|
-6.30 score on a scale
Standard Error 9
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16 and 24 weeksPopulation: The FAS was not administered to participants.
The FAS is a 10-item general fatigue questionnaire to assess fatigue. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: KSQ was not administered to participants.
The KSQ is a free, online questionnaire to be filled out by sarcoidosis patients. The questionnaire takes around 10 minutes and is split into 5 sections; general health status, lungs, medication, skin and eyes. There are 29 questions in total, however some questions may not be answered (depending on the type of sarcoidosis affected). Each question asks patients to rate how they feel about many different aspects of their life, for instance how much pain they are in or how difficult they find everyday tasks. Information provided is confidential. Results are given as a number between 1-100 with higher numbers indicating better health.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksSafety profile of regimen as evidenced by the number of adverse events
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=49 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Adverse Events
Serious Adverse Events
|
4 number of events
|
3 number of events
|
|
Adverse Events
Non-Serious Adverse Events
|
24 number of events
|
16 number of events
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, and 16 and 24 weeksPopulation: Week 24 assessment was optional. Not all participants completed all measurements
FEV1% was measure pre and post 6 minute walk test
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=49 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
FEV1%
24 weeks post
|
73.09 Percentage of predicted FEV1
Standard Error 18.333
|
66.27 Percentage of predicted FEV1
Standard Error 19.78
|
|
FEV1%
Baseline pre
|
69.11 Percentage of predicted FEV1
Standard Error 17.23
|
67.45 Percentage of predicted FEV1
Standard Error 17.85
|
|
FEV1%
Baseline post
|
69.97 Percentage of predicted FEV1
Standard Error 17.01
|
73.81 Percentage of predicted FEV1
Standard Error 18.91
|
|
FEV1%
4 weeks pre
|
71.57 Percentage of predicted FEV1
Standard Error 17.31
|
69.56 Percentage of predicted FEV1
Standard Error 20.52
|
|
FEV1%
4 weeks post
|
71.96 Percentage of predicted FEV1
Standard Error 16.46
|
73.81 Percentage of predicted FEV1
Standard Error 18.91
|
|
FEV1%
8 weeks pre
|
69.30 Percentage of predicted FEV1
Standard Error 17.22
|
73.71 Percentage of predicted FEV1
Standard Error 19.01
|
|
FEV1%
8 weeks post
|
70.36 Percentage of predicted FEV1
Standard Error 17.62
|
74.3 Percentage of predicted FEV1
Standard Error 19.05
|
|
FEV1%
16 weeks pre
|
69.88 Percentage of predicted FEV1
Standard Error 16.5
|
68.27 Percentage of predicted FEV1
Standard Error 20.17
|
|
FEV1%
16 weeks post
|
71.39 Percentage of predicted FEV1
Standard Error 18.33
|
70.41 Percentage of predicted FEV1
Standard Error 20.03
|
|
FEV1%
24 weeks pre
|
72.22 Percentage of predicted FEV1
Standard Error 17.73
|
63.27 Percentage of predicted FEV1
Standard Error 20.17
|
SECONDARY outcome
Timeframe: Baseline to 16 weeksWe will assess how many subjects in either arm need escalation of their standard regimen (ie increase in prednisone) during the 16 weeks.
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=43 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Failure of Standard Therapy
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: baseline to 16 weeksSafety profile of regimen as evidenced by the number of abnormal lab values classified as Adverse Events
Outcome measures
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=49 Participants
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 Participants
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Abnormal Lab Values
low glucose
|
1 participants
|
1 participants
|
|
Abnormal Lab Values
low platelet count
|
1 participants
|
0 participants
|
|
Abnormal Lab Values
low WBC count
|
5 participants
|
0 participants
|
|
Abnormal Lab Values
elevated glucose
|
3 participants
|
2 participants
|
Adverse Events
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=49 participants at risk
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 participants at risk
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
1/49 • Number of events 1 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/49 • Number of events 1 • 24 weeks
|
2.1%
1/48 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Neurosarcoidosis
|
2.0%
1/49 • Number of events 1 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Cardiac disorders
Hypotension
|
2.0%
1/49 • Number of events 1 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Infections and infestations
Sepsis from Abcess
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • Number of events 1 • 24 weeks
|
|
Infections and infestations
post-operative infection
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin
n=49 participants at risk
Levofloxacin 500mg po QD; Ethambutol 1200mg po QD; Azithromycin 250 mg po QD; Rifampin 600mg po QD or Rifabutin 300mg po QD
Levofloxacin
Ethambutol
Azithromycin
Rifampin
|
Placebo
n=48 participants at risk
Riboflavin will be used for rifampin; encapsulated microcrystalline cellulose will be used to replace the levofloxacin, ethambutol and azithromycin.
The pill count will be the same as the comparator regimen.
Placebo: This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Low Platelet count
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Blood and lymphatic system disorders
Low WBC Count
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Blood and lymphatic system disorders
leukopenia
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Blood and lymphatic system disorders
WBC Low
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Blood and lymphatic system disorders
Low WBC
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Cardiac disorders
Hypotension
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Ear and labyrinth disorders
Loss of Hearing in Right Ear
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Endocrine disorders
Elevated Glucose
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Endocrine disorders
hypoglycemia
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Endocrine disorders
Worsening Glucose
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Endocrine disorders
elevated glucose
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Eye disorders
Floater/Blurry Vision
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Eye disorders
Eyes red & draining
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Gastrointestinal disorders
diarrhea
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
loss of appetite
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
weakness
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
nausea
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
diarrhea/loose stool
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
Nausea, Vomiting, Diarrhea
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
Nauseated, Vomiting & Diarrhea
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
nausea, vomitting, diarrhea
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Gastrointestinal disorders
Surgey (Appendectomy)
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Gastrointestinal disorders
Nausea & Diarrhea
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea, loss of appetite,
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
General disorders
Fever, Nausea, Chills
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Fever
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
increase in hair loss
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Fatigue
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Insomnia
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Urine Color change
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Tiredness/Fatigue
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
flu-like symptoms (chills, aches, fatigue)
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Dehydration
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Hospitalization
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Right Upper Quadant Pain
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
fever, chills
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
General disorders
Pruritus
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
General disorders
Chills
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
General disorders
Tiredness
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
General disorders
Hard to swallow
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Hepatobiliary disorders
elevated LFTs
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Infections and infestations
yeast infection
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Infections and infestations
Shingles
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Infections and infestations
Yeast Infection, (Urine Urgency, Fever, Joint Aches)
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Infections and infestations
Foot Abscess
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Injury, poisoning and procedural complications
Reaction to medication
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Injury, poisoning and procedural complications
broken foot and fibula
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
joint pain and achiness
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffiness
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle/flank/joint pain
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Nervous system disorders
confusion
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Psychiatric disorders
depression
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Psychiatric disorders
Anxiety, Insomnia
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Renal and urinary disorders
Kidney stone pain
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
SOB/Fatigue
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough, fever chills, pain with breathing
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Elevated Glucose
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus blockage
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough, wheeze, congestion
|
0.00%
0/49 • 24 weeks
|
2.1%
1/48 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • 24 weeks
|
0.00%
0/48 • 24 weeks
|
Additional Information
Wonder Drake, MD
Vanderbilt University Medical Center
Phone: (615) 322-2035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place