Trial Outcomes & Findings for A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC) (NCT NCT00600119)
NCT ID: NCT00600119
Last Updated: 2015-06-12
Results Overview
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
207 participants
Primary outcome timeframe
Days 1 through 7
Results posted on
2015-06-12
Participant Flow
This multicenter study was conducted in Canada, Germany, Romania, and the United States between 04 January 2008 and 23 March 2009.
The study duration was up to 11 weeks, consisting of an initial screening period lasting up to 10 days, a 14-day OIC confirmation period, during which the OIC diagnosis was confirmed, a 7-day single-blind placebo run-in period, a 29-day double-blind treatment period, and a follow-up visit 2 weeks after the last dose of study drug.
Participant milestones
| Measure |
Placebo 5 mg
Placebo for NKTR-118 5 mg QD, oral treatment
|
NKTR-118 5 mg
NKTR-118 5 mg QD, oral treatment
|
Placebo 25 mg
Placebo for NKTR-118 25 mg QD, oral treatment
|
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Placebo 50 mg
Placebo for NKTR-118 50 mg QD, oral treatment
|
NKTR-118 50 mg
NKTR-118 50 mg QD, oral treatment
|
|---|---|---|---|---|---|---|
|
Single-blind Placebo run-in Period
STARTED
|
36
|
35
|
29
|
31
|
39
|
37
|
|
Single-blind Placebo run-in Period
COMPLETED
|
32
|
33
|
27
|
30
|
37
|
35
|
|
Single-blind Placebo run-in Period
NOT COMPLETED
|
4
|
2
|
2
|
1
|
2
|
2
|
|
Double-blind Treatment Period
STARTED
|
32
|
33
|
27
|
30
|
37
|
35
|
|
Double-blind Treatment Period
COMPLETED
|
27
|
28
|
27
|
28
|
31
|
21
|
|
Double-blind Treatment Period
NOT COMPLETED
|
5
|
5
|
0
|
2
|
6
|
14
|
|
Follow-up Period
STARTED
|
27
|
28
|
27
|
28
|
31
|
21
|
|
Follow-up Period
COMPLETED
|
26
|
28
|
27
|
28
|
31
|
20
|
|
Follow-up Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo 5 mg
Placebo for NKTR-118 5 mg QD, oral treatment
|
NKTR-118 5 mg
NKTR-118 5 mg QD, oral treatment
|
Placebo 25 mg
Placebo for NKTR-118 25 mg QD, oral treatment
|
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Placebo 50 mg
Placebo for NKTR-118 50 mg QD, oral treatment
|
NKTR-118 50 mg
NKTR-118 50 mg QD, oral treatment
|
|---|---|---|---|---|---|---|
|
Single-blind Placebo run-in Period
Other - Not specified
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Single-blind Placebo run-in Period
Inclusion/Exclusion Criteria Not Met
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Single-blind Placebo run-in Period
Sponsor Decision
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Single-blind Placebo run-in Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Single-blind Placebo run-in Period
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Single-blind Placebo run-in Period
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
0
|
3
|
|
Double-blind Treatment Period
Other
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Double-blind Treatment Period
Inclusion/Exclusion Criteria Not Met
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Double-blind Treatment Period
Moderate to Severe Opioid Withdrawal
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period
Sponsor Decision
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Double-blind Treatment Period
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period
Adverse Event
|
1
|
1
|
0
|
1
|
2
|
10
|
|
Follow-up Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Follow-up Period
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Baseline characteristics by cohort
| Measure |
Placebo 5 mg
n=31 Participants
Placebo for NKTR-118 5 mg QD, oral treatment
|
NKTR-118 5 mg
n=31 Participants
NKTR-118 5 mg QD, oral treatment
|
Placebo 25 mg
n=27 Participants
Placebo for NKTR-118 25 mg QD, oral treatment
|
NKTR-118 25 mg
n=29 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo 50 mg
n=37 Participants
Placebo for NKTR-118 50 mg QD, oral treatment
|
NKTR-118 50 mg
n=30 Participants
NKTR-118 50 mg QD, oral treatment
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.5 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
50.3 Years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
51.0 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
51.8 Years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
48.4 Years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
49.6 Years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
49.7 Years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
115 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
70 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
160 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Allowed to Ask
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
Outcome measures
| Measure |
Placebo 5 mg
n=31 Participants
Placebo for NKTR-118 5 mg QD, oral treatment
|
NKTR-118 5 mg
n=31 Participants
NKTR-118 5 mg QD, oral treatment
|
Placebo 25 mg
n=27 Participants
Placebo for NKTR-118 25 mg QD, oral treatment
|
NKTR-118 25 mg
n=29 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo 50 mg
n=37 Participants
Placebo for NKTR-118 50 mg QD, oral treatment
|
NKTR-118 50 mg
n=30 Participants
NKTR-118 50 mg QD, oral treatment
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
|
1.8 Number of SBMs/week
Standard Deviation 2.4
|
2.6 Number of SBMs/week
Standard Deviation 3.6
|
1.9 Number of SBMs/week
Standard Deviation 2.5
|
3.6 Number of SBMs/week
Standard Deviation 2.3
|
1.9 Number of SBMs/week
Standard Deviation 5.2
|
4.4 Number of SBMs/week
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Days 1 through 28Population: The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).
Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.
Outcome measures
| Measure |
Placebo 5 mg
n=31 Participants
Placebo for NKTR-118 5 mg QD, oral treatment
|
NKTR-118 5 mg
n=31 Participants
NKTR-118 5 mg QD, oral treatment
|
Placebo 25 mg
n=27 Participants
Placebo for NKTR-118 25 mg QD, oral treatment
|
NKTR-118 25 mg
n=29 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo 50 mg
n=37 Participants
Placebo for NKTR-118 50 mg QD, oral treatment
|
NKTR-118 50 mg
n=30 Participants
NKTR-118 50 mg QD, oral treatment
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
|
1.7 Number of SBMs/week
Standard Deviation 1.9
|
2.3 Number of SBMs/week
Standard Deviation 2.9
|
1.7 Number of SBMs/week
Standard Deviation 2.2
|
3.2 Number of SBMs/week
Standard Deviation 2.0
|
1.2 Number of SBMs/week
Standard Deviation 2.0
|
4.6 Number of SBMs/week
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Days 1 through 28Population: The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).
The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo 5 mg
n=28 Participants
Placebo for NKTR-118 5 mg QD, oral treatment
|
NKTR-118 5 mg
n=30 Participants
NKTR-118 5 mg QD, oral treatment
|
Placebo 25 mg
n=25 Participants
Placebo for NKTR-118 25 mg QD, oral treatment
|
NKTR-118 25 mg
n=28 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo 50 mg
n=35 Participants
Placebo for NKTR-118 50 mg QD, oral treatment
|
NKTR-118 50 mg
n=29 Participants
NKTR-118 50 mg QD, oral treatment
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Total Score
|
1.5 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 0.8
|
1.2 units on a scale
Standard Deviation 0.8
|
1.6 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Physical Discomfort domain
|
1.4 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 1.0
|
1.7 units on a scale
Standard Deviation 1.1
|
1.3 units on a scale
Standard Deviation 1.0
|
|
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Worries/Concerms domain
|
1.5 units on a scale
Standard Deviation 1.1
|
1.3 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 1.1
|
1.1 units on a scale
Standard Deviation 0.9
|
1.5 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Psychosocial Discomfort domain
|
0.8 units on a scale
Standard Deviation 0.7
|
0.8 units on a scale
Standard Deviation 0.8
|
1.1 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 0.8
|
1.0 units on a scale
Standard Deviation 0.9
|
0.8 units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Satisfaction domain
|
2.6 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.1
|
2.8 units on a scale
Standard Deviation 0.9
|
2.0 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.1
|
2.2 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Days 1 through 28Population: The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).
The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo 5 mg
n=28 Participants
Placebo for NKTR-118 5 mg QD, oral treatment
|
NKTR-118 5 mg
n=30 Participants
NKTR-118 5 mg QD, oral treatment
|
Placebo 25 mg
n=25 Participants
Placebo for NKTR-118 25 mg QD, oral treatment
|
NKTR-118 25 mg
n=28 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo 50 mg
n=35 Participants
Placebo for NKTR-118 50 mg QD, oral treatment
|
NKTR-118 50 mg
n=29 Participants
NKTR-118 50 mg QD, oral treatment
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Rectal Symptoms domain
|
0.7 units on a scale
Standard Deviation 0.8
|
0.7 units on a scale
Standard Deviation 0.7
|
0.8 units on a scale
Standard Deviation 0.8
|
0.7 units on a scale
Standard Deviation 0.8
|
1.2 units on a scale
Standard Deviation 1.0
|
0.7 units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Stool Symptoms domain
|
1.5 units on a scale
Standard Deviation 1.0
|
1.5 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 0.8
|
1.2 units on a scale
Standard Deviation 0.9
|
1.8 units on a scale
Standard Deviation 1.1
|
1.2 units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Total Score
|
1.2 units on a scale
Standard Deviation 0.8
|
1.2 units on a scale
Standard Deviation 0.7
|
1.4 units on a scale
Standard Deviation 0.6
|
1.1 units on a scale
Standard Deviation 0.8
|
1.5 units on a scale
Standard Deviation 1.0
|
1.1 units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Abdominal Symptoms domain
|
1.2 units on a scale
Standard Deviation 0.8
|
1.1 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 0.9
|
1.1 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 1.0
|
1.3 units on a scale
Standard Deviation 1.0
|
Adverse Events
NKTR-118 25 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
NKTR-118 5 mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
NKTR-118 50 mg
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo 25 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo 5 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo 50 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NKTR-118 25 mg
n=30 participants at risk
|
NKTR-118 5 mg
n=33 participants at risk
|
NKTR-118 50 mg
n=35 participants at risk
|
Placebo 25 mg
n=27 participants at risk
|
Placebo 5 mg
n=32 participants at risk
|
Placebo 50 mg
n=37 participants at risk
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/35
|
0.00%
0/27
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/35
|
0.00%
0/27
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/30
|
0.00%
0/33
|
2.9%
1/35 • Number of events 1
|
0.00%
0/27
|
0.00%
0/32
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/35
|
0.00%
0/27
|
0.00%
0/32
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/35
|
0.00%
0/27
|
0.00%
0/32
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/35
|
0.00%
0/27
|
0.00%
0/32
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/35
|
0.00%
0/27
|
0.00%
0/32
|
0.00%
0/37
|
Other adverse events
| Measure |
NKTR-118 25 mg
n=30 participants at risk
|
NKTR-118 5 mg
n=33 participants at risk
|
NKTR-118 50 mg
n=35 participants at risk
|
Placebo 25 mg
n=27 participants at risk
|
Placebo 5 mg
n=32 participants at risk
|
Placebo 50 mg
n=37 participants at risk
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/30
|
6.1%
2/33 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
0.00%
0/37
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
30.0%
9/30 • Number of events 12
|
3.0%
1/33 • Number of events 1
|
17.1%
6/35 • Number of events 9
|
7.4%
2/27 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
10.0%
3/30 • Number of events 4
|
18.2%
6/33 • Number of events 6
|
25.7%
9/35 • Number of events 10
|
3.7%
1/27 • Number of events 1
|
0.00%
0/32
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHOEA
|
13.3%
4/30 • Number of events 4
|
15.2%
5/33 • Number of events 5
|
31.4%
11/35 • Number of events 11
|
3.7%
1/27 • Number of events 1
|
15.6%
5/32 • Number of events 5
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.0%
3/30 • Number of events 5
|
3.0%
1/33 • Number of events 1
|
8.6%
3/35 • Number of events 3
|
14.8%
4/27 • Number of events 4
|
3.1%
1/32 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
FLATULENCE
|
6.7%
2/30 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
8.6%
3/35 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
0.00%
0/37
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/30
|
12.1%
4/33 • Number of events 4
|
2.9%
1/35 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
13.3%
4/30 • Number of events 5
|
15.2%
5/33 • Number of events 7
|
20.0%
7/35 • Number of events 7
|
18.5%
5/27 • Number of events 5
|
6.2%
2/32 • Number of events 2
|
8.1%
3/37 • Number of events 3
|
|
Gastrointestinal disorders
VOMITING
|
13.3%
4/30 • Number of events 4
|
0.00%
0/33
|
11.4%
4/35 • Number of events 4
|
3.7%
1/27 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
5.4%
2/37 • Number of events 2
|
|
General disorders
CHILLS
|
3.3%
1/30 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
0.00%
0/32
|
0.00%
0/37
|
|
General disorders
FATIGUE
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
2.9%
1/35 • Number of events 1
|
0.00%
0/27
|
6.2%
2/32 • Number of events 2
|
2.7%
1/37 • Number of events 1
|
|
General disorders
PAIN
|
10.0%
3/30 • Number of events 3
|
9.1%
3/33 • Number of events 3
|
2.9%
1/35 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/30
|
6.1%
2/33 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
0.00%
0/27
|
3.1%
1/32 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.7%
2/30 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
0.00%
0/27
|
9.4%
3/32 • Number of events 3
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
7.4%
2/27 • Number of events 3
|
0.00%
0/32
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.7%
2/30 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
0.00%
0/35
|
0.00%
0/27
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
|
Nervous system disorders
DIZZINESS
|
6.7%
2/30 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
0.00%
0/35
|
14.8%
4/27 • Number of events 5
|
6.2%
2/32 • Number of events 2
|
0.00%
0/37
|
|
Nervous system disorders
HEADACHE
|
6.7%
2/30 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
6.2%
2/32 • Number of events 3
|
2.7%
1/37 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
3.3%
1/30 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
0.00%
0/27
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
6.7%
2/30 • Number of events 2
|
15.2%
5/33 • Number of events 6
|
8.6%
3/35 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60