Trial Outcomes & Findings for Prostaglandin Inhibition for Emphysema (NCT NCT02006576)

Results Overview

PGE will be measured by HPLC in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

118 participants

Primary outcome timeframe

12 weeks after subject randomization

Results posted on

2023-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	COPD, Placebo Placebo three times daily Placebo three times daily	Control Subject Control subjects, no intervention	COPD, Ibuprofen 600 mg ibuprofen three times daily for 48 weeks 600 mg ibuprofen three times daily for 48 weeks
Overall Study STARTED	35	51	32
Overall Study COMPLETED	17	44	15
Overall Study NOT COMPLETED	18	7	17

Reasons for withdrawal

Reasons for withdrawal
Measure	COPD, Placebo Placebo three times daily Placebo three times daily	Control Subject Control subjects, no intervention	COPD, Ibuprofen 600 mg ibuprofen three times daily for 48 weeks 600 mg ibuprofen three times daily for 48 weeks
Overall Study Withdrawal by Subject	4	6	2
Overall Study Death	0	0	1
Overall Study Lost to Follow-up	1	0	1
Overall Study Screen Failure, too sick, other	13	1	13

Baseline Characteristics

Sex is missing for one person.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COPD, Placebo n=35 Participants Placebo three times daily Placebo three times daily	Control Subject n=51 Participants Control subjects, no intervention	COPD, Ibuprofen n=32 Participants 600 mg ibuprofen three times daily for 48 weeks 600 mg ibuprofen three times daily for 48 weeks	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=51 Participants	0 Participants n=32 Participants	0 Participants n=118 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=35 Participants	37 Participants n=51 Participants	17 Participants n=32 Participants	75 Participants n=118 Participants
Age, Categorical >=65 years	14 Participants n=35 Participants	14 Participants n=51 Participants	15 Participants n=32 Participants	43 Participants n=118 Participants
Age, Continuous	63.8 years n=35 Participants	58.8 years n=51 Participants	63.9 years n=32 Participants	60.9 years n=118 Participants
Sex: Female, Male Female	16 Participants n=35 Participants • Sex is missing for one person.	24 Participants n=51 Participants • Sex is missing for one person.	15 Participants n=31 Participants • Sex is missing for one person.	55 Participants n=117 Participants • Sex is missing for one person.
Sex: Female, Male Male	19 Participants n=35 Participants • Sex is missing for one person.	27 Participants n=51 Participants • Sex is missing for one person.	16 Participants n=31 Participants • Sex is missing for one person.	62 Participants n=117 Participants • Sex is missing for one person.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=51 Participants	0 Participants n=32 Participants	0 Participants n=118 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=51 Participants	0 Participants n=32 Participants	0 Participants n=118 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=51 Participants	0 Participants n=32 Participants	0 Participants n=118 Participants
Race (NIH/OMB) Black or African American	11 Participants n=35 Participants	21 Participants n=51 Participants	9 Participants n=32 Participants	41 Participants n=118 Participants
Race (NIH/OMB) White	12 Participants n=35 Participants	27 Participants n=51 Participants	11 Participants n=32 Participants	50 Participants n=118 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=51 Participants	0 Participants n=32 Participants	0 Participants n=118 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=35 Participants	3 Participants n=51 Participants	12 Participants n=32 Participants	27 Participants n=118 Participants
Region of Enrollment United States	35 participants n=35 Participants	51 participants n=51 Participants	32 participants n=32 Participants	118 participants n=118 Participants

PRIMARY outcome

Timeframe: 12 weeks after subject randomization

Population: Primary analysis limited to COPD Placebo vs. Ibuprofen groups only. The 'control' group is assessed once and serves as a comparator for the post treatment ibuprofen group.

PGE will be measured by HPLC in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

Outcome measures

Outcome measures
Measure	COPD, Placebo n=17 Participants Placebo three times daily Placebo three times daily	Control Subject Control subjects, no intervention	COPD, Ibuprofen n=15 Participants 600 mg ibuprofen three times daily for 48 weeks 600 mg ibuprofen three times daily for 48 weeks
Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo?	0.003 Change in ng/ml Standard Deviation 0.080	—	-0.156 Change in ng/ml Standard Deviation 0.455

SECONDARY outcome

Timeframe: 12 weeks after subject randomization

Population: This analysis limited to COPD Placebo vs. Ibuprofen groups only.

Pro-collagen peptide fragments will be measured by ELISA in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

Outcome measures

Outcome measures
Measure	COPD, Placebo n=16 Participants Placebo three times daily Placebo three times daily	Control Subject Control subjects, no intervention	COPD, Ibuprofen n=13 Participants 600 mg ibuprofen three times daily for 48 weeks 600 mg ibuprofen three times daily for 48 weeks
Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo?	-1.060 Change in ng/ml Standard Deviation 8.729	—	0.011 Change in ng/ml Standard Deviation 0.584

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after subject randomization

Comparing ibuprofen, 600 mg three times daily, in reducing prostaglandin E concentrations in the alveolar portion of bronchoalveolar lavage (BAL) fluid in participants with emphysema to those present in smoking, former smoking and healthy non-smoking controls? Prostaglandin E (PGE) will be measured by HPLC in alveolar fluids obtained at randomization and again 12 weeks after randomization on subjects taking ibuprofen to compare emphysema subjects, smokers, former smokers and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after subject randomization

PGE will be measured by HPLC in bronchial fluids obtained at randomization and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks after subject randomization

PGE will be measured by HPLC in sputum samples obtained prior to randomization and again 10 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smokers and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

PGEM will be measured by HPLC in peripheral blood specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

PGEM will be measured by HPLC in urine specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

Pro-collagen peptide fragment concentrations will be measured by ELISA in alveolar fluids obtained at randomization and again 12 weeks after randomization to determine if levels reach those of normal individuals or reach even higher levels.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

Procollagen III amino peptide will be measured by ELISA in urine specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

IL-8 will be measured by ELISA in alveolar specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

Neutrophils will be measured by 500 cell differentials in alveolar specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

IL-8 will be measured by ELISA in bronchial specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks after randomization

IL-8 will be measured by ELISA in sputum specimens obtained prior to randomization and 10 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

Neutrophils will be measured by 500 cell differentials in bronchial specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks after randomization

Neutrophils will be measured by 500 cell differentials in bronchial specimens obtained prior to randomization and 10 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

LTB4 will be measured by HPLC in alveolar fluids, bronchial fluids and induced sputums obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

CC-16 will be measured by ELISA in serum specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

CRP will be measured by ELISA in serum specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

SP-d will be measured by ELISA in serum specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

PGD will be measured by HPLC in alveolar fluids obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. PGD levels will be compared against FEV1 and severity of emphysema.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

TXB2 will be measured by HPLC in alveolar fluids obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. TXB2 levels will be compared against FEV1 and severity of emphysema.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

6kPGF1a will be measured by HPLC in alveolar fluids obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. 6kPGF1a levels will be compared against FEV1 and severity of emphysema.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after randomization

LTB4, PGD, TXB2, and 6kPGF1a will be measured by HPLC in induced sputums and BAL's obtained prior to randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

CT scans will be used to evaluated the rate of change of emphysema for participants taking 600 mg of ibuprofen three times a day

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

Spirometry will be used to test lung function \[diffusing capacity of the lungs for carbon monoxide (DLCO)\] to assess the lungs' ability to transfer gas from inspired air to the bloodstream in participants taking 600 mg of ibuprofen three times a day.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

Evaluation of 600 mg of Ibuprofen three times a day on forced expiratory volume (FEV1) rate of change. FEV1 calculates the amount of air that a person can force out of their lungs in 1 second. FEV1 values that are lower than average suggest the presence of COPD.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

Evaluation of the rate of chronic obstructive pulmonary disease (COPD) exacerbations in participants taking 600 mg of Ibuprofen three times a day.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

Evaluation of 600 mg of Ibuprofen three times a day on health status of participants with emphysema as assessed by St. George's Respiratory Questionnaire (SGRQ) or chronic obstructive pulmonary disease (COPD) status as assessed by computed axial tomography (CAT). St. George's Respiratory Questionnaire (SGRQ) is a type of questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Chronic obstructive pulmonary disease, or COPD, refers to a group of diseases that cause airflow blockage and breathing-related problems. It includes emphysema and chronic bronchitis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

PGE levels in BAL fluid, sputum and metabolites in blood and urine will be evaluated for differences between subjects with upper lobe vs. lower lobe emphysema. Procollagen peptides will be evaluated in BAL fluid between subjects with upper lobe vs. lower lobe emphysema. Eicosanoids (PGD, 6kPGF1a, TXB2) urine will be evaluated between subjects with upper lobe vs. lower lobe emphysema. Measures of inflammation will be evaluated between subjects with upper vs. lower lobe emphysema. Does the response of PGE, measures of repair, response of other eicosanoids, and response of measures of inflammation change as a result of 600 mg three times daily of ibuprofen.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks after randomization

PGE levels in BAL fluid, sputum and metabolites in blood and urine will be evaluated for differences between subjects with clustered versus diffuse emphysema. Procollagen peptides will be evaluated in BAL fluid between subjects with clustered versus diffuse emphysema. Eicosanoids (PGD, 6kPGF1a, TXB2) urine will be evaluated between subjects with clustered versus diffuse emphysema. Measures of inflammation will be evaluated between subjects with clustered versus diffuse emphysema. Does the response of PGE, measures of repair, response of other eicosanoids, and response of measures of inflammation change as a result of 600 mg three times daily of ibuprofen.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-6 years from initial CT scan

Evaluation of prostaglandin E (PGE) levels obtained by bronchoalveolar lavage (BAL) and emphysema progression as determined by change in computed tomography (CT) quantified lung density.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-6 years from initial FEV1 assessment

Evaluation of prostaglandin E (PGE) levels obtained by bronchoalveolar lavage (BAL) and emphysema progression as determined by change in forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. FEV1 values that are lower than average suggest the presence of COPD.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-6 years from initial CT scan

Comparing measures of prostanoids, other than PGE, to the rate of emphysema progression as determined by the change in computed tomography (CT) quantified lung density from assessment to end of study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-6 years after initial FEV1 assessment

Emphysema progression as determined by the change in forced expiratory volume (FEV1) from assessment to end of study. FEV1 calculates the amount of air that a person can force out of their lungs in 1 second. FEV1 values that are lower than average suggest the presence of COPD.

Outcome measures

Outcome data not reported

Adverse Events

COPD, Placebo

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Control Subject

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

COPD, Ibuprofen

Serious events: 2 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	COPD, Placebo n=35 participants at risk Placebo three times daily Placebo three times daily	Control Subject n=51 participants at risk Control subjects, no intervention	COPD, Ibuprofen n=32 participants at risk 600 mg ibuprofen three times daily for 48 weeks 600 mg ibuprofen three times daily for 48 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia	2.9% 1/35 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.9% 1/35 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/32 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Musculoskeletal and connective tissue disorders Left Chest Pain	2.9% 1/35 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/32 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	2.9% 1/35 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.

Other adverse events

Other adverse events
Measure	COPD, Placebo n=35 participants at risk Placebo three times daily Placebo three times daily	Control Subject n=51 participants at risk Control subjects, no intervention	COPD, Ibuprofen n=32 participants at risk 600 mg ibuprofen three times daily for 48 weeks 600 mg ibuprofen three times daily for 48 weeks
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	2.9% 1/35 • Number of events 2 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	6.2% 2/32 • Number of events 2 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
General disorders Headache	2.9% 1/35 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonis	2.9% 1/35 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/32 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Blood and lymphatic system disorders Positive Occult Blood	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Respiratory, thoracic and mediastinal disorders AECOPD	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	9.4% 3/32 • Number of events 4 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Respiratory, thoracic and mediastinal disorders Acute Sinus Infection	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Gastrointestinal disorders Mild benign-appearing intrinsic stenosis	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Musculoskeletal and connective tissue disorders Left Hip Pain	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Gastrointestinal disorders Viral Gastroenteresis	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Respiratory, thoracic and mediastinal disorders Cough and Chest Congestion	0.00% 0/35 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	3.1% 1/32 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.
Gastrointestinal disorders Vomiting	2.9% 1/35 • Number of events 1 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/51 • Three year period from the first study visit through the last completed study visit on at 48 weeks.	0.00% 0/32 • Three year period from the first study visit through the last completed study visit on at 48 weeks.

Additional Information

Amy Nelson

University of Nebraska Medical Center

Phone: 402-559-5536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place