Trial Outcomes & Findings for A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT02871401)
NCT ID: NCT02871401
Last Updated: 2022-04-29
Results Overview
Proportion of study subjects who discontinue study drug due to adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-04-29
Participant Flow
Participant milestones
| Measure |
Valganciclovir
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
11
|
|
Overall Study
COMPLETED
|
19
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Valganciclovir
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
Valganciclovir
n=20 Participants
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 Participants
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
68.2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 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
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Forced vital capacity (FVC) % predicted for age
|
69.4 %
STANDARD_DEVIATION 19.0 • n=5 Participants
|
69.4 %
STANDARD_DEVIATION 7.7 • n=7 Participants
|
69.4 %
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Forced expiratory volume in 1 second (FEV1) % predicted for age
|
76.9 %
STANDARD_DEVIATION 20.5 • n=5 Participants
|
79.7 %
STANDARD_DEVIATION 10.8 • n=7 Participants
|
77.9 %
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Total Lung Capacity (TLC) % predicted for age
|
62.2 %
STANDARD_DEVIATION 17.7 • n=5 Participants
|
62.1 %
STANDARD_DEVIATION 7.2 • n=7 Participants
|
62.2 %
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Diffusion capacity for carbon monoxide (DLCO) % predicted for age
|
47.3 %
STANDARD_DEVIATION 10.2 • n=5 Participants
|
41.0 %
STANDARD_DEVIATION 8.9 • n=7 Participants
|
45.0 %
STANDARD_DEVIATION 10.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksProportion of study subjects who discontinue study drug due to adverse events
Outcome measures
| Measure |
Valganciclovir
n=20 Participants
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 Participants
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of subjects with each reported adverse event
Outcome measures
| Measure |
Valganciclovir
n=20 Participants
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 Participants
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Adverse Events - Number
Rash
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Weight loss
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Worsening anemia
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Worsening hypertension
|
1 participants
|
0 participants
|
|
Adverse Events - Number
At least 1 AE
|
14 participants
|
4 participants
|
|
Adverse Events - Number
Cough
|
3 participants
|
1 participants
|
|
Adverse Events - Number
Leukocytosis
|
1 participants
|
3 participants
|
|
Adverse Events - Number
Diarrhea
|
2 participants
|
0 participants
|
|
Adverse Events - Number
Elevated liver enzymes
|
2 participants
|
0 participants
|
|
Adverse Events - Number
Pneumonia
|
2 participants
|
0 participants
|
|
Adverse Events - Number
Worsened dyspnea
|
0 participants
|
2 participants
|
|
Adverse Events - Number
Acute pain of shoulder
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Acute respiratory failure
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Acute sinusitis
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Bilateral arm swelling
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Bilateral lower leg edema
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Carbuncle on face
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Depression
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Dyspepsia
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Hoarseness
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Hypertension
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Hypoxia during flight
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Jaw pain
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Lymphopenia
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Nausea
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Nephrolithiasis
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Pain in back
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Paroxysmal atrial fibrillation
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Prostate cancer recurrence
|
0 participants
|
1 participants
|
|
Adverse Events - Number
Respiratory tract infection
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Sore throat
|
1 participants
|
1 participants
|
|
Adverse Events - Number
Thrombocytopenia
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Tooth pain
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Upper respiratory tract infection
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Vertigo
|
1 participants
|
0 participants
|
|
Adverse Events - Number
Weakness
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Serious adverse events
Number of subjects with each serious adverse event
Outcome measures
| Measure |
Valganciclovir
n=20 Participants
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 Participants
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Serious Adverse Events
|
2 events
|
1 events
|
SECONDARY outcome
Timeframe: Randomization to 16 weeksTotal number of adverse events
Outcome measures
| Measure |
Valganciclovir
n=20 Participants
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 Participants
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Total # Adverse Events
|
33 events
|
13 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline vs. 12 weeks, 1 yearPopulation: PFT data not available at 1 year (obtained per standard of-care at clinical visit) for 5 subjects. Reasons for missing data: Decreased (n=1), moved out of region and lost to follow-up (n=1), PFT's not obtained at visit (n=3).
Change in FVC percent predicted compared to baseline
Outcome measures
| Measure |
Valganciclovir
n=20 Participants
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 Participants
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
Baseline to 12 weeks
|
0 percentage predicted
Interval -1.0 to 2.0
|
-2 percentage predicted
Interval -4.0 to 2.0
|
|
Change in Forced Vital Capacity (FVC)
Baseline to 12 months
|
-1 percentage predicted
Interval -4.0 to 1.0
|
-5 percentage predicted
Interval -10.0 to 1.0
|
Adverse Events
Valganciclovir
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Valganciclovir
n=20 participants at risk
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 participants at risk
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/20 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
Other adverse events
| Measure |
Valganciclovir
n=20 participants at risk
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Valganciclovir: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
Placebo
n=11 participants at risk
Placebo, 2 pills by mouth one time per day x 12 weeks
Placebo: Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
27.3%
3/11 • Number of events 3 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/20 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Infections and infestations
Acute sinusitis
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Skin and subcutaneous tissue disorders
Bilateral upper extremity edema
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Skin and subcutaneous tissue disorders
BIlateral lower extremity edema
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Infections and infestations
Carbuncle
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
General disorders
Hoarseness
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia during flight
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
General disorders
Jaw pain
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/20 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in back
|
0.00%
0/20 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Infections and infestations
Respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
General disorders
Sore throat
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
General disorders
Tooth pain
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
General disorders
Weight loss
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/20 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Cardiac disorders
Worsening hypertension
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
0.00%
0/11 • Adverse event data were collected from baseline through active treatment (week 12) and 4 weeks of additional follow-up.
AE's were assessed by study personnel at each study visit.
|
Additional Information
Jonathan Kropski MD
Vanderbilt University Medical Center
Phone: 615-322-3412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place