Trial Outcomes & Findings for Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis (NCT NCT03451045)
NCT ID: NCT03451045
Last Updated: 2023-01-18
Results Overview
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
447 participants
Primary outcome timeframe
28 weeks (Baseline Day 0 to Week 28)
Results posted on
2023-01-18
Participant Flow
Participant milestones
| Measure |
Lenabasum 20 mg BID
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo
subjects received placebo BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
175
|
91
|
181
|
|
Overall Study
COMPLETED
|
148
|
85
|
154
|
|
Overall Study
NOT COMPLETED
|
27
|
6
|
27
|
Reasons for withdrawal
| Measure |
Lenabasum 20 mg BID
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo
subjects received placebo BID
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
5
|
|
Overall Study
Pregnancy
|
0
|
0
|
2
|
|
Overall Study
Adverse Event
|
7
|
1
|
3
|
|
Overall Study
Non-compliance with study
|
2
|
0
|
1
|
|
Overall Study
any other reason
|
10
|
2
|
13
|
Baseline Characteristics
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Lenabasum 20 mg BID
n=165 Participants
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 Participants
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo
n=171 Participants
subjects received placebo BID
|
Total
n=425 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.2 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
28.9 years
STANDARD_DEVIATION 11.24 • n=7 Participants
|
26.6 years
STANDARD_DEVIATION 10.81 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
403 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 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
|
1 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
410 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Body Mass Index
|
21.07 kg/m^2
STANDARD_DEVIATION 3.179 • n=5 Participants
|
22.26 kg/m^2
STANDARD_DEVIATION 4.164 • n=7 Participants
|
21.52 kg/m^2
STANDARD_DEVIATION 3.931 • n=5 Participants
|
21.50 kg/m^2
STANDARD_DEVIATION 3.728 • n=4 Participants
|
|
FEV1 (L)
|
2.10 liters
STANDARD_DEVIATION 0.73 • n=5 Participants
|
2.20 liters
STANDARD_DEVIATION 0.77 • n=7 Participants
|
2.17 liters
STANDARD_DEVIATION 0.75 • n=5 Participants
|
2.15 liters
STANDARD_DEVIATION 0.76 • n=4 Participants
|
|
Number of Acute Pulmonary Exacerbations in Past Year
one
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Number of Acute Pulmonary Exacerbations in Past Year
two
|
75 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Number of Acute Pulmonary Exacerbations in Past Year
three
|
63 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Number of Acute Pulmonary Exacerbations in Past Year
four
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Number of Acute Pulmonary Exacerbations in Past Year
five
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Number of Acute Pulmonary Exacerbations in Past Year
six or more
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
CFTR Genotype
F508del/F508del
|
83 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
CFTR Genotype
F508del/other
|
56 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
CFTR Genotype
Other/other or unknown
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Weight
|
58.41 kg
STANDARD_DEVIATION 11.567 • n=5 Participants
|
62.82 kg
STANDARD_DEVIATION 15.540 • n=7 Participants
|
59.25 kg
STANDARD_DEVIATION 13.645 • n=5 Participants
|
59.67 kg
STANDARD_DEVIATION 13.390 • n=4 Participants
|
PRIMARY outcome
Timeframe: 28 weeks (Baseline Day 0 to Week 28)Population: modified intent to treat population
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.
Outcome measures
| Measure |
Lenabasum 20 mg BID
n=165 Participants
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 Participants
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo BID
n=171 Participants
Placebo: Subjects will receive placebo twice daily.
|
|---|---|---|---|
|
Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
|
0.911 events per participant/28 weeks
|
0.749 events per participant/28 weeks
|
0.842 events per participant/28 weeks
|
SECONDARY outcome
Timeframe: 28 weeks (Baseline Day 0 to Week 28)Population: modified intent to treat population
Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks
Outcome measures
| Measure |
Lenabasum 20 mg BID
n=165 Participants
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 Participants
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo BID
n=171 Participants
Placebo: Subjects will receive placebo twice daily.
|
|---|---|---|---|
|
Pulmonary Exacerbation (PEx) Rate
|
1.08 events per participant/28 weeks
|
0.91 events per participant/28 weeks
|
1.03 events per participant/28 weeks
|
SECONDARY outcome
Timeframe: 28 weeks (Baseline Day 0 to Week 28)Population: modified intent to treat population
Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit
Outcome measures
| Measure |
Lenabasum 20 mg BID
n=165 Participants
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 Participants
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo BID
n=171 Participants
Placebo: Subjects will receive placebo twice daily.
|
|---|---|---|---|
|
Time to First New Pulmonary Exacerbation (PEx)
|
162 days
Interval 59.0 to 183.0
|
148 days
Interval 58.0 to 183.0
|
143 days
Interval 58.0 to 183.0
|
SECONDARY outcome
Timeframe: 28 weeks (Baseline Day 0 to Week 28)Population: modified intent to treat population
Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx.
Outcome measures
| Measure |
Lenabasum 20 mg BID
n=165 Participants
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 Participants
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo BID
n=171 Participants
Placebo: Subjects will receive placebo twice daily.
|
|---|---|---|---|
|
Pulmonary Exacerbation (PEx)
|
116 days
Interval 38.0 to 183.0
|
113 days
Interval 54.0 to 183.0
|
120 days
Interval 49.0 to 183.0
|
SECONDARY outcome
Timeframe: 28 weeks (Change from Baseline Day 0 to Week 28)Population: modified intent to treat population
Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects \>/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Outcome measures
| Measure |
Lenabasum 20 mg BID
n=165 Participants
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 Participants
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo BID
n=171 Participants
Placebo: Subjects will receive placebo twice daily.
|
|---|---|---|---|
|
CFQ-R Respiratory Symptom Domain
|
1.16 scores on a scale
Standard Error 1.41
|
-2.92 scores on a scale
Standard Error 1.88
|
-0.96 scores on a scale
Standard Error 1.41
|
SECONDARY outcome
Timeframe: 28 weeks (Change from Baseline Day 0 to Week 28)Population: modified intent to treat population
Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants.
Outcome measures
| Measure |
Lenabasum 20 mg BID
n=165 Participants
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 Participants
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo BID
n=171 Participants
Placebo: Subjects will receive placebo twice daily.
|
|---|---|---|---|
|
FEV1 % Predicted
|
0.014 percentage of Predicted FEV1
Standard Error 0.025
|
-0.005 percentage of Predicted FEV1
Standard Error 0.033
|
-0.012 percentage of Predicted FEV1
Standard Error 0.025
|
Adverse Events
Lenabasum 20 mg BID
Serious events: 50 serious events
Other events: 151 other events
Deaths: 0 deaths
Lenabasum 5 mg BID
Serious events: 25 serious events
Other events: 80 other events
Deaths: 0 deaths
Placebo
Serious events: 50 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenabasum 20 mg BID
n=165 participants at risk
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 participants at risk
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo
n=171 participants at risk
subjects received placebo BID
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Cardiac disorders
Tachcardia
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Congenital, familial and genetic disorders
Non-compaction cardiomyopathy
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
1.8%
3/165 • Number of events 3 • 28 weeks
|
1.1%
1/89 • Number of events 1 • 28 weeks
|
1.8%
3/171 • Number of events 3 • 28 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
General disorders
Pyrexia
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Infections and infestations
Fungal disease carrier
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
1.2%
2/171 • Number of events 2 • 28 weeks
|
|
Infections and infestations
Pharyngitis
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Investigations
Forced expiratory volume decreased
|
0.61%
1/165 • Number of events 2 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
1.2%
2/171 • Number of events 2 • 28 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Investigations
Human rhinovirus test positive
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Investigations
Pulmonary function test positive
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/165 • 28 weeks
|
1.1%
1/89 • Number of events 1 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/165 • 28 weeks
|
1.1%
1/89 • Number of events 1 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/165 • 28 weeks
|
1.1%
1/89 • Number of events 1 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/165 • 28 weeks
|
1.1%
1/89 • Number of events 1 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.00%
0/171 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
3/165 • Number of events 3 • 28 weeks
|
1.1%
1/89 • Number of events 1 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Infective pulmonary exacerbation of cystic fibrosis
|
25.5%
42/165 • Number of events 61 • 28 weeks
|
24.7%
22/89 • Number of events 29 • 28 weeks
|
24.0%
41/171 • Number of events 53 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/165 • 28 weeks
|
0.00%
0/89 • 28 weeks
|
0.58%
1/171 • Number of events 1 • 28 weeks
|
Other adverse events
| Measure |
Lenabasum 20 mg BID
n=165 participants at risk
Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
|
Lenabasum 5 mg BID
n=89 participants at risk
Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
|
Placebo
n=171 participants at risk
subjects received placebo BID
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
27.3%
45/165 • Number of events 79 • 28 weeks
|
25.8%
23/89 • Number of events 53 • 28 weeks
|
25.1%
43/171 • Number of events 80 • 28 weeks
|
|
General disorders
General disorders and administration site conditions
|
23.6%
39/165 • Number of events 70 • 28 weeks
|
24.7%
22/89 • Number of events 33 • 28 weeks
|
19.3%
33/171 • Number of events 41 • 28 weeks
|
|
Immune system disorders
Immune system disorders
|
1.2%
2/165 • Number of events 6 • 28 weeks
|
3.4%
3/89 • Number of events 4 • 28 weeks
|
2.9%
5/171 • Number of events 7 • 28 weeks
|
|
Infections and infestations
Infections and infestations
|
45.5%
75/165 • Number of events 112 • 28 weeks
|
40.4%
36/89 • Number of events 54 • 28 weeks
|
42.1%
72/171 • Number of events 114 • 28 weeks
|
|
Investigations
Investigations
|
21.2%
35/165 • Number of events 65 • 28 weeks
|
24.7%
22/89 • Number of events 50 • 28 weeks
|
17.5%
30/171 • Number of events 60 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissues
|
10.3%
17/165 • Number of events 20 • 28 weeks
|
15.7%
14/89 • Number of events 17 • 28 weeks
|
10.5%
18/171 • Number of events 22 • 28 weeks
|
|
Nervous system disorders
Nervous system
|
24.8%
41/165 • Number of events 65 • 28 weeks
|
20.2%
18/89 • Number of events 31 • 28 weeks
|
16.4%
28/171 • Number of events 40 • 28 weeks
|
|
Psychiatric disorders
Psychiatric
|
6.7%
11/165 • Number of events 12 • 28 weeks
|
11.2%
10/89 • Number of events 10 • 28 weeks
|
6.4%
11/171 • Number of events 13 • 28 weeks
|
|
Renal and urinary disorders
Renal and urinary
|
0.61%
1/165 • Number of events 1 • 28 weeks
|
5.6%
5/89 • Number of events 10 • 28 weeks
|
4.7%
8/171 • Number of events 10 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal
|
72.7%
120/165 • Number of events 385 • 28 weeks
|
73.0%
65/89 • Number of events 201 • 28 weeks
|
71.3%
122/171 • Number of events 367 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous
|
7.3%
12/165 • Number of events 13 • 28 weeks
|
5.6%
5/89 • Number of events 7 • 28 weeks
|
9.9%
17/171 • Number of events 21 • 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place