Trial Outcomes & Findings for Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults. (NCT NCT02273167)
NCT ID: NCT02273167
Last Updated: 2018-05-15
Results Overview
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
849 participants
Primary outcome timeframe
Up to 2 days (from day of first dosing to day of colonoscopy)
Results posted on
2018-05-15
Participant Flow
The trial recruited out/in-patients at 29 medical centres in Europe, from October 2014 to June 2015.
Participant milestones
| Measure |
MOVIPREP, 2-Day Split-Dosing
MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Overall Study
STARTED
|
283
|
283
|
283
|
|
Overall Study
COMPLETED
|
259
|
260
|
262
|
|
Overall Study
NOT COMPLETED
|
24
|
23
|
21
|
Reasons for withdrawal
| Measure |
MOVIPREP, 2-Day Split-Dosing
MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
12
|
11
|
|
Overall Study
Various
|
10
|
9
|
8
|
Baseline Characteristics
Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.
Baseline characteristics by cohort
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=283 Participants
MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=283 Participants
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=283 Participants
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
Total
n=849 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
228 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
639 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 12.03 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 12.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
454 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
395 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 days (from day of first dosing to day of colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.
Outcome measures
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=272 Participants
MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=275 Participants
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=275 Participants
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Number of Patients With Successful Bowel Cleansing (Overall Colon)
Successful
|
238 Participants
|
253 Participants
|
245 Participants
|
|
Number of Patients With Successful Bowel Cleansing (Overall Colon)
Failure
|
34 Participants
|
22 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: Up to 2 days (from day of first dosing to day of colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.
Outcome measures
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=272 Participants
MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=275 Participants
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=275 Participants
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Excellent plus good
|
41 Participants
|
87 Participants
|
93 Participants
|
|
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Adequate plus failure
|
231 Participants
|
188 Participants
|
182 Participants
|
SECONDARY outcome
Timeframe: Up to 2 days (from day of first dosing to day of colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.
Outcome measures
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=272 Participants
MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=275 Participants
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=275 Participants
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Adenoma Detection Rate (Colon Ascendens)
Patients with at least one adenoma detected
|
22 Participants
|
32 Participants
|
32 Participants
|
|
Adenoma Detection Rate (Colon Ascendens)
Patients with no adenomas detected
|
250 Participants
|
243 Participants
|
243 Participants
|
SECONDARY outcome
Timeframe: Up to 2 days (from day of first dosing to day of colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.
Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.
Outcome measures
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=272 Participants
MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=275 Participants
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=275 Participants
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Adenoma Detection Rate (Overall Colon)
Patients with no adenomas detected
|
199 Participants
|
202 Participants
|
199 Participants
|
|
Adenoma Detection Rate (Overall Colon)
Patients with at least one adenoma detected
|
73 Participants
|
73 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Up to 2 days (from day of first dosing to day of colonoscopy)Population: The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug
Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.
Outcome measures
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=272 Participants
MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=275 Participants
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=275 Participants
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Polyp Detection Rate (Colon Ascendens)
Patients with no polyps detected
|
228 Participants
|
211 Participants
|
224 Participants
|
|
Polyp Detection Rate (Colon Ascendens)
Patients with at least one polyp detected
|
44 Participants
|
64 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Up to 2 days (from day of first dosing to day of colonoscopy)Population: The overall number of participants analysed is based on the mFAS. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).
Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. PDR defined as the number of patients with at least one polyp in the overall colon.
Outcome measures
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=272 Participants
MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=275 Participants
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=275 Participants
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Polyp Detection Rate (Overall Colon)
Patients with at least one polyp detected
|
121 Participants
|
121 Participants
|
124 Participants
|
|
Polyp Detection Rate (Overall Colon)
Patients with no polyps detected
|
151 Participants
|
154 Participants
|
151 Participants
|
Adverse Events
MOVIPREP, 2-Day Split-Dosing
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
NER1006, 2-Day Split-Dosing
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
NER1006,1-Day Morning Split-Dosing
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=263 participants at risk
MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=262 participants at risk
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=269 participants at risk
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/263 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.38%
1/262 • Number of events 1 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.00%
0/269 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/263 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.38%
1/262 • Number of events 1 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.00%
0/269 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
Other adverse events
| Measure |
MOVIPREP, 2-Day Split-Dosing
n=263 participants at risk
MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006, 2-Day Split-Dosing
n=262 participants at risk
NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
|
NER1006,1-Day Morning Split-Dosing
n=269 participants at risk
NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
6/263 • Number of events 6 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.1%
3/262 • Number of events 3 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.37%
1/269 • Number of events 1 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.38%
1/263 • Number of events 1 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.00%
0/262 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.1%
3/269 • Number of events 3 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/263 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.1%
3/262 • Number of events 3 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.1%
3/269 • Number of events 3 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Gastrointestinal disorders
Nausea
|
3.4%
9/263 • Number of events 9 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
5.7%
15/262 • Number of events 16 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
5.2%
14/269 • Number of events 14 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/263 • Number of events 3 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
4.2%
11/262 • Number of events 11 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
6.7%
18/269 • Number of events 18 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
General disorders
Fatigue
|
1.9%
5/263 • Number of events 5 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.00%
0/262 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.00%
0/269 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
General disorders
Feeling cold
|
1.5%
4/263 • Number of events 4 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.00%
0/262 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.37%
1/269 • Number of events 1 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
General disorders
Thirst
|
0.76%
2/263 • Number of events 2 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.76%
2/262 • Number of events 2 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.9%
5/269 • Number of events 5 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Nervous system disorders
Headache
|
1.5%
4/263 • Number of events 4 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.5%
4/262 • Number of events 4 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.74%
2/269 • Number of events 3 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.38%
1/263 • Number of events 1 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.38%
1/262 • Number of events 1 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.5%
4/269 • Number of events 4 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
|
Vascular disorders
Hypertension
|
0.00%
0/263 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
0.76%
2/262 • Number of events 2 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
|
1.1%
3/269 • Number of events 3 • Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)
Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place