Trial Outcomes & Findings for Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation (NCT NCT01309841)
NCT ID: NCT01309841
Last Updated: 2015-06-01
Results Overview
Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.
COMPLETED
PHASE3
652 participants
Baseline (Week 1) to end of treatment (Week 12)
2015-06-01
Participant Flow
This multicenter study was conducted in Australia, Germany, Slovakia, and the United States between 14 March 2011 and 16 August 2012.
The study duration was up to 18 weeks, consisting of an initial screening period lasting up to 2 weeks, a 2-week OIC confirmation period, during which the diagnosis of OIC and stability of the opioid regimen were confirmed, a 12-week treatment period, and a follow-up visit 2 weeks after the last dose of study drug.
Participant milestones
| Measure |
NKTR-118 12.5 mg
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Placebo
Placebo QD, oral treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
217
|
218
|
217
|
|
Overall Study
COMPLETED
|
178
|
177
|
180
|
|
Overall Study
NOT COMPLETED
|
39
|
41
|
37
|
Reasons for withdrawal
| Measure |
NKTR-118 12.5 mg
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Placebo
Placebo QD, oral treatment
|
|---|---|---|---|
|
Overall Study
Other
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
4
|
|
Overall Study
Study-Specific Withdrawal Criteria
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
|
Overall Study
Adverse Event
|
9
|
22
|
11
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Eligibility Criteria Not Fulfilled
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
17
|
6
|
13
|
|
Overall Study
Did Not Receive Treatment
|
2
|
0
|
1
|
|
Overall Study
Severe non-compliance with protocol
|
0
|
5
|
2
|
Baseline Characteristics
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Baseline characteristics by cohort
| Measure |
NKTR-118 12.5 mg
n=213 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=214 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=214 Participants
Placebo QD, oral treatment
|
Total
n=641 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.9 Years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
52.2 Years
STANDARD_DEVIATION 10.29 • n=7 Participants
|
52.9 Years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
52.3 Years
STANDARD_DEVIATION 10.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
393 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
248 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
164 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
497 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Baseline laxative response status
Laxative Inadequate Response (LIR)
|
115 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
350 Participants
n=4 Participants
|
|
Baseline laxative response status
Laxative Adequate Response (LAR)
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Baseline laxative response status
Laxative Unknown Response (LUR)
|
95 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.
Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=213 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=214 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=214 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
|
87 Number of patients
|
95 Number of patients
|
63 Number of patients
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.
Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=115 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=117 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=118 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12
|
49 Number of patients
|
57 Number of patients
|
34 Number of patients
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=213 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=214 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=214 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours
|
20.4 Hours
Interval 11.5 to 22.7
|
5.9 Hours
Interval 4.8 to 11.5
|
35.8 Hours
Interval 27.0 to 48.1
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=211 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=212 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=211 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12
|
2.21 Number of Days
Standard Error 0.13
|
2.48 Number of Days
Standard Error 0.13
|
1.66 Number of Days
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.
A single-item straining question was asked via the eDiary: "How much did you strain during your bowel movement?" Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=211 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=212 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=211 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Degree of Straining
|
-0.64 units on a scale
Standard Error 0.05
|
-0.73 units on a scale
Standard Error 0.05
|
-0.54 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.
Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=211 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=212 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=211 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Stool Consistency (Bristol Stool Scale)
|
0.53 units on a scale
Standard Error 0.07
|
0.66 units on a scale
Standard Error 0.07
|
0.47 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.
A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: "Did you feel like your bowels were completely empty after the bowel movement?" Patients provided a yes or a no response. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=211 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=212 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=211 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)
|
22.31 Percent days/week
Standard Error 1.73
|
27.04 Percent days/week
Standard Error 1.75
|
18.45 Percent days/week
Standard Error 1.72
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.
The number of spontaneous bowel movements/week was determined from the patient's eDiary.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=211 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=212 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=211 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Mean Spontaneous Bowel Movements/Week
|
2.56 Number of SBMs/week
Standard Error 0.18
|
3.02 Number of SBMs/week
Standard Error 0.18
|
2.02 Number of SBMs/week
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.
Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue - First dose date/time.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=115 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=117 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=118 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup
|
20.6 hours
Interval 8.1 to 23.5
|
5.4 hours
Interval 3.9 to 10.7
|
43.4 hours
Interval 25.2 to 48.2
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.
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 of the domain or total score 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 |
NKTR-118 12.5 mg
n=171 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=158 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=173 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Total score
|
-0.76 units on a scale
Standard Error 0.05
|
-0.81 units on a scale
Standard Error 0.05
|
-0.69 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Abdominal symptoms subscore
|
-0.61 units on a scale
Standard Error 0.06
|
-0.65 units on a scale
Standard Error 0.06
|
-0.63 units on a scale
Standard Error 0.06
|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Rectal symptoms subscore
|
-0.66 units on a scale
Standard Error 0.05
|
-0.73 units on a scale
Standard Error 0.05
|
-0.53 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Stool symptoms subscore
|
-0.96 units on a scale
Standard Error 0.07
|
-1.00 units on a scale
Standard Error 0.07
|
-0.84 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline (Week 1) to end of treatment (Week 12)Population: The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.
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 of the domain or total score 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 |
NKTR-118 12.5 mg
n=172 Participants
NKTR-118 12.5 QD, oral treatment
|
NKTR-118 25 mg
n=159 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=174 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain
|
-0.91 units on a scale
Standard Error 0.09
|
-1.06 units on a scale
Standard Error 0.09
|
-0.89 units on a scale
Standard Error 0.09
|
Adverse Events
NKTR-118 12.5 mg
NKTR-118 25 mg
Placebo
Serious adverse events
| Measure |
NKTR-118 12.5 mg
n=211 participants at risk
|
NKTR-118 25 mg
n=214 participants at risk
|
Placebo
n=213 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
Gastrointestinal disorders
FLATULENCE
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Gastrointestinal disorders
SIGMOIDITIS
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.47%
1/211 • Number of events 1
|
0.93%
2/214 • Number of events 2
|
0.47%
1/213 • Number of events 1
|
|
General disorders
PYREXIA
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 2
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.95%
2/211 • Number of events 2
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Injury, poisoning and procedural complications
CARDIAC VALVE REPLACEMENT COMPLICATION
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER STAGE I
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
Nervous system disorders
BASILAR MIGRAINE
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/211
|
0.47%
1/214 • Number of events 1
|
0.00%
0/213
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.00%
0/211
|
0.00%
0/214
|
0.47%
1/213 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
0.47%
1/211 • Number of events 1
|
0.00%
0/214
|
0.00%
0/213
|
Other adverse events
| Measure |
NKTR-118 12.5 mg
n=211 participants at risk
|
NKTR-118 25 mg
n=214 participants at risk
|
Placebo
n=213 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.0%
19/211 • Number of events 21
|
12.1%
26/214 • Number of events 28
|
3.3%
7/213 • Number of events 8
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.4%
3/211 • Number of events 3
|
5.1%
11/214 • Number of events 13
|
1.9%
4/213 • Number of events 5
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.3%
7/211 • Number of events 8
|
8.9%
19/214 • Number of events 20
|
4.2%
9/213 • Number of events 9
|
|
Gastrointestinal disorders
FLATULENCE
|
3.8%
8/211 • Number of events 8
|
5.6%
12/214 • Number of events 12
|
2.3%
5/213 • Number of events 5
|
|
Gastrointestinal disorders
NAUSEA
|
7.6%
16/211 • Number of events 19
|
7.5%
16/214 • Number of events 19
|
4.7%
10/213 • Number of events 10
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
3.3%
7/211 • Number of events 7
|
2.3%
5/214 • Number of events 5
|
1.9%
4/213 • Number of events 4
|
|
Gastrointestinal disorders
VOMITING
|
1.9%
4/211 • Number of events 4
|
3.3%
7/214 • Number of events 12
|
3.3%
7/213 • Number of events 7
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.8%
6/211 • Number of events 6
|
3.7%
8/214 • Number of events 8
|
3.3%
7/213 • Number of events 7
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.4%
5/211 • Number of events 6
|
0.00%
0/214
|
2.8%
6/213 • Number of events 6
|
|
Injury, poisoning and procedural complications
FALL
|
1.4%
3/211 • Number of events 3
|
1.4%
3/214 • Number of events 3
|
2.8%
6/213 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/211
|
3.7%
8/214 • Number of events 8
|
2.3%
5/213 • Number of events 5
|
|
Nervous system disorders
DIZZINESS
|
1.4%
3/211 • Number of events 4
|
0.00%
0/214
|
2.3%
5/213 • Number of events 5
|
|
Nervous system disorders
HEADACHE
|
2.4%
5/211 • Number of events 5
|
3.7%
8/214 • Number of events 8
|
1.9%
4/213 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/211
|
4.2%
9/214 • Number of events 9
|
0.47%
1/213 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60