Trial Outcomes & Findings for Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis (NCT NCT00770913)
NCT ID: NCT00770913
Last Updated: 2012-04-18
Results Overview
Grade N indicates a normal appearance of lower esophageal mucosa
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
337 participants
Primary outcome timeframe
8 weeks
Results posted on
2012-04-18
Participant Flow
This study was recruited at 71 centers in Japan during the period of 17-Oct-2008 to 12-Nov-2009.
There was no run-in phase before assignment to E3810 treatment groups in this study.
Participant milestones
| Measure |
E3810 20 mg Once Daily
E3810 20mg once daily orally for 8 weeks
|
E3810 10 mg Twice Daily
E3810 10mg twice daily orally for 8 weeks
|
E3810 20 mg Twice Daily
E3810 20mg twice daily orally for 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
113
|
111
|
113
|
|
Overall Study
COMPLETED
|
102
|
103
|
100
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
13
|
Reasons for withdrawal
| Measure |
E3810 20 mg Once Daily
E3810 20mg once daily orally for 8 weeks
|
E3810 10 mg Twice Daily
E3810 10mg twice daily orally for 8 weeks
|
E3810 20 mg Twice Daily
E3810 20mg twice daily orally for 8 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
6
|
|
Overall Study
Refusal to continue participation
|
6
|
4
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
0
|
1
|
|
Overall Study
Incorrect drug was allocated
|
1
|
0
|
0
|
Baseline Characteristics
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
Baseline characteristics by cohort
| Measure |
E3810 20 mg Once Daily
n=110 Participants
E3810 20mg once daily orally for 8 weeks
|
E3810 10 mg Twice Daily
n=111 Participants
E3810 10mg twice daily orally for 8 weeks
|
E3810 20 mg Twice Daily
n=111 Participants
E3810 20mg twice daily orally for 8 weeks
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
64.5 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
110 participants
n=5 Participants
|
111 participants
n=7 Participants
|
111 participants
n=5 Participants
|
332 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The primary analysis was on the full analysis set (FAS) population.
Grade N indicates a normal appearance of lower esophageal mucosa
Outcome measures
| Measure |
E3810 20 mg Once Daily
n=113 Participants
E3810 20 mg once daily orally for 8 weeks
|
E3810 10 mg Twice Daily
n=111 Participants
E3810 10 mg twice daily orally for 8 weeks
|
E3810 20 mg
n=113 Participants
E3810 20 mg twice daily orally for 8 weeks
|
|---|---|---|---|
|
Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)
|
58.8 Percentage of Participants
|
78.4 Percentage of Participants
|
77.0 Percentage of Participants
|
Adverse Events
E3810 20 mg Once Daily
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
E3810 10 mg Twice Daily
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
E3810 20 mg
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E3810 20 mg Once Daily
n=112 participants at risk
E3810 20 mg once daily orally for 8 weeks
|
E3810 10 mg Twice Daily
n=111 participants at risk
E3810 10 mg twice daily orally for 8 weeks
|
E3810 20 mg
n=114 participants at risk
E3810 20 mg twice daily orally for 8 weeks
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.90%
1/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.89%
1/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.90%
1/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.90%
1/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.90%
1/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.89%
1/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.90%
1/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.89%
1/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.90%
1/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
Other adverse events
| Measure |
E3810 20 mg Once Daily
n=112 participants at risk
E3810 20 mg once daily orally for 8 weeks
|
E3810 10 mg Twice Daily
n=111 participants at risk
E3810 10 mg twice daily orally for 8 weeks
|
E3810 20 mg
n=114 participants at risk
E3810 20 mg twice daily orally for 8 weeks
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.1%
8/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
6.3%
7/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
3.5%
4/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.6%
4/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
1.8%
2/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
1.8%
2/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
2/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
2.7%
3/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
4.4%
5/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
4.5%
5/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
3/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.00%
0/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.7%
3/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
6.3%
7/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
6.1%
7/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
|
Investigations
Blood triglycerides increased
|
4.5%
5/112
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.90%
1/111
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
0.88%
1/114
The safety population includes all participants who took at least one dose of the assigned intervention. No.of Participants Analyzed: 113, 111, 113.Participants affected/at risk: 112, 111, 114. The drug was incorrectly prescribed. It should have been 20mg twice daily, but 20mg once daily was mistakenly prescribed despite of correct allocation.
|
Additional Information
Tomoki Kubota, Study Director
Eisai Co.,Ltd. Eisai Product Creation Systems
Phone: +81-3-3817-3908
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place