Trial Outcomes & Findings for Mepo for Eosinophilic Esophagitis (EoE) Study (NCT NCT03656380)
NCT ID: NCT03656380
Last Updated: 2023-08-23
Results Overview
Dysphagia will be assessed by the Eosinophilic Esophagitis Symptom Activity Index (EEsAI) which measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Baseline, Month 3 Post-Treatment
Results posted on
2023-08-23
Participant Flow
Participant milestones
| Measure |
Mepolizumab 300 mg
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
Received Intervention
|
32
|
33
|
|
Overall Study
Completed Month 3
|
31
|
33
|
|
Overall Study
Subsequent 3 Months of Treatment (Part 2)
|
28
|
28
|
|
Overall Study
Completed Month 6
|
28
|
28
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mepo for Eosinophilic Esophagitis (EoE) Study
Baseline characteristics by cohort
| Measure |
Mepolizumab 300 mg
n=32 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=34 Participants
Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 12 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
35.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3 Post-TreatmentDysphagia will be assessed by the Eosinophilic Esophagitis Symptom Activity Index (EEsAI) which measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Outcome measures
| Measure |
Mepolizumab 300 mg
n=31 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=33 Participants
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Mean Change in Dysphagia Score
|
15.4 score on a scale
Standard Deviation 18.1
|
8.3 score on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: After 3 months of treatmentThe EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Outcome measures
| Measure |
Mepolizumab 300 mg
n=31 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=33 Participants
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Percent of Participants With a Clinical Remission (EEsAI Score of ≤ 20 Points)
|
6.45 percent of participants
|
6.06 percent of participants
|
SECONDARY outcome
Timeframe: After 3 months of treatmentThe EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Outcome measures
| Measure |
Mepolizumab 300 mg
n=31 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=33 Participants
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Percent of Participants With a Clinical Response (EEsAI Score Decrease of ≥ 20 Points)
|
35.48 percent of participants
|
21.21 percent of participants
|
SECONDARY outcome
Timeframe: After 3 months of treatmentAbsolute peak eosinophil (EOS) count (measured in EOS/hpf) after 3 months of treatment.
Outcome measures
| Measure |
Mepolizumab 300 mg
n=31 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=33 Participants
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Absolute Peak Eosinophil Count
|
35.7 eosinophils per high power field
Standard Deviation 43
|
163 eosinophils per high power field
Standard Deviation 133.1
|
SECONDARY outcome
Timeframe: After 3 months of treatmentNumber of participants with a histologic response as assessed by having \<15, ≤ 6, and ≤ 1 Eosinophils per high powered field (EOS/hpf).
Outcome measures
| Measure |
Mepolizumab 300 mg
n=31 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=33 Participants
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field
<15 eos/hpf
|
13 Participants
|
1 Participants
|
|
Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field
≤6 eos/hpf
|
7 Participants
|
1 Participants
|
|
Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field
≤1 eos/hpf
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months post-treatmentMean change in severity of endoscopic findings as measured by the EoE (Eosinophilic Esophagitis) Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema as absent (0) or present (1); furrows as absent (0), mild (1), or severe (2); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9).
Outcome measures
| Measure |
Mepolizumab 300 mg
n=31 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=33 Participants
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Mean Change in Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)
|
1 score on a scale
Standard Deviation 1.1
|
0.4 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months post-treatmentThe Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia.
Outcome measures
| Measure |
Mepolizumab 300 mg
n=31 Participants
Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months
Mepolizumab 300 mg: Mepolizumab 300 mg subcutaneous injection
|
Placebo, Followed by Mepolizumab 100 mg
n=33 Participants
This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg: Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|
|
Mean Change in the Straumann Dysphagia Instrument (SDI) Score
|
2.4 score on a scale
Standard Deviation 1.7
|
2.7 score on a scale
Standard Deviation 2.2
|
Adverse Events
Mepolizumab 300 mg: Baseline to Month 3
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Only to Month 3
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Mepolizumab 300 mg Continuing to 6 Months
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Switch to Mepolizumab 100 mg: Month 3 to Month 6
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mepolizumab 300 mg: Baseline to Month 3
n=32 participants at risk
Subjects received Mepolizumab 300 mg subcutaneously (SQ) monthly for 3 months.
Mepolizumab 300 mg subcutaneous injection
|
Placebo Only to Month 3
n=34 participants at risk
Subjects received placebo subcutaneously (SQ) monthly for 3 months.
Placebo: Saline subcutaneous injection
|
Mepolizumab 300 mg Continuing to 6 Months
n=28 participants at risk
Subjects continued to receive Mepolizumab 300 mg subcutaneously (SQ) monthly through month 6.
Mepolizumab 300 mg subcutaneous injection
|
Placebo Switch to Mepolizumab 100 mg: Month 3 to Month 6
n=28 participants at risk
After the first 3 months of placebo, subjects received 3 months of Mepolizumab 100 mg subcutaneously (SQ) monthly. Mepolizumab was administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
3.1%
1/32 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/34 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
3.1%
1/32 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/34 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Musculoskeletal and connective tissue disorders
Spinal decompression surgery
|
0.00%
0/32 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/34 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Musculoskeletal and connective tissue disorders
Orthopoedic Surgery
|
0.00%
0/32 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/34 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Surgical and medical procedures
Corrective Jaw Surgery
|
0.00%
0/32 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/34 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
Other adverse events
| Measure |
Mepolizumab 300 mg: Baseline to Month 3
n=32 participants at risk
Subjects received Mepolizumab 300 mg subcutaneously (SQ) monthly for 3 months.
Mepolizumab 300 mg subcutaneous injection
|
Placebo Only to Month 3
n=34 participants at risk
Subjects received placebo subcutaneously (SQ) monthly for 3 months.
Placebo: Saline subcutaneous injection
|
Mepolizumab 300 mg Continuing to 6 Months
n=28 participants at risk
Subjects continued to receive Mepolizumab 300 mg subcutaneously (SQ) monthly through month 6.
Mepolizumab 300 mg subcutaneous injection
|
Placebo Switch to Mepolizumab 100 mg: Month 3 to Month 6
n=28 participants at risk
After the first 3 months of placebo, subjects received 3 months of Mepolizumab 100 mg subcutaneously (SQ) monthly. Mepolizumab was administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding.
Mepolizumab 100 mg subcutaneous injection
Placebo: Saline subcutaneous injection
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
28.1%
9/32 • Number of events 14 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
11.8%
4/34 • Number of events 4 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
28.6%
8/28 • Number of events 12 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
17.9%
5/28 • Number of events 5 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
General disorders
Injection site bruise
|
3.1%
1/32 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
8.8%
3/34 • Number of events 4 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
7.1%
2/28 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
14.3%
4/28 • Number of events 4 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
8.8%
3/34 • Number of events 4 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
10.7%
3/28 • Number of events 4 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Infections and infestations
COVID-19
|
0.00%
0/32 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
11.8%
4/34 • Number of events 4 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
General disorders
Fatigue
|
9.4%
3/32 • Number of events 3 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
5.9%
2/34 • Number of events 3 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
General disorders
Flu-like symptoms
|
3.1%
1/32 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
8.8%
3/34 • Number of events 4 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
5.9%
2/34 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Gastrointestinal disorders
Sore Throat
|
3.1%
1/32 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
5.9%
2/34 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Gastrointestinal disorders
Esophageal Pain
|
0.00%
0/32 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
5.9%
2/34 • Number of events 3 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
2.9%
1/34 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
7.1%
2/28 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/32 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
5.9%
2/34 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
5.9%
2/34 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
0.00%
0/28 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
|
Infections and infestations
Upper Respiratory Infection
|
3.1%
1/32 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
2.9%
1/34 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
3.6%
1/28 • Number of events 1 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
7.1%
2/28 • Number of events 2 • Baseline through Month 6 post treatment assessments
Adverse events were captured from time of consent (prior to group assignment) through Month 6.
|
Additional Information
Lindsay Cortright, MA
University of North Carolina at Chapel Hill
Phone: 919-445-4911
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place