Trial Outcomes & Findings for A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation (NCT NCT01395524)
NCT ID: NCT01395524
Last Updated: 2017-02-23
Results Overview
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Baseline (Week 0) to end of the follow-up period (Week 14)
Results posted on
2017-02-23
Participant Flow
This multicenter study was conducted in the United States between 07 July 2011 and 13 September 2012.
Study D380C00007 is an extension study of D3820C00004. Of the patients randomized in D3820C00004, n=302 continued and enrolled into D380C00007. The study duration was up to 14 weeks, consisting of 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 mg QD, oral treatment
|
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Placebo
Placebo QD, oral treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
97
|
99
|
106
|
|
Overall Study
COMPLETED
|
79
|
83
|
89
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
17
|
Reasons for withdrawal
| Measure |
NKTR-118 12.5 mg
NKTR-118 12.5 mg QD, oral treatment
|
NKTR-118 25 mg
NKTR-118 25 mg QD, oral treatment
|
Placebo
Placebo QD, oral treatment
|
|---|---|---|---|
|
Overall Study
Non-compliance with study schedule
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
|
Overall Study
Study-Specific Withdrawal Criteria
|
1
|
2
|
0
|
|
Overall Study
Severe noncompliance with protocol
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
4
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Eligibility Criteria Not Fulfilled
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
8
|
|
Overall Study
Did not receive treatment
|
1
|
1
|
3
|
|
Overall Study
Subject had spinal surgery
|
0
|
0
|
1
|
Baseline Characteristics
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Baseline characteristics by cohort
| Measure |
NKTR-118 12.5 mg
n=95 Participants
NKTR-118 12.5 mg QD, oral treatment
|
NKTR-118 25 mg
n=98 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=103 Participants
Placebo QD, oral treatment
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.8 Years
STANDARD_DEVIATION 9.51 • n=99 Participants
|
52.6 Years
STANDARD_DEVIATION 10.19 • n=107 Participants
|
52.6 Years
STANDARD_DEVIATION 10.00 • n=206 Participants
|
52.3 Years
STANDARD_DEVIATION 9.89 • n=7 Participants
|
|
Gender
Female
|
62 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
180 Participants
n=7 Participants
|
|
Gender
Male
|
33 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
71 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
221 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to end of the follow-up period (Week 14)Population: The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=94 Participants
NKTR-118 12.5 mg QD, oral treatment
|
NKTR-118 25 mg
n=97 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=100 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Incidence of Patients Experiencing at Least One Adverse Event (AE)
|
32 Participants
|
40 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to end of the follow-up period (Week 14)Population: The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=94 Participants
NKTR-118 12.5 mg QD, oral treatment
|
NKTR-118 25 mg
n=97 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=100 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
|
4 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to end of the follow-up period (Week 14)Population: The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Outcome measures
| Measure |
NKTR-118 12.5 mg
n=94 Participants
NKTR-118 12.5 mg QD, oral treatment
|
NKTR-118 25 mg
n=97 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=100 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
|
6 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)Population: The modified intent-to-treat(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 N denotes the number of patients with a baseline and last on-treatment value.
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=84 Participants
NKTR-118 12.5 mg QD, oral treatment
|
NKTR-118 25 mg
n=90 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=97 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Total score
|
-0.9 units on a scale
Standard Deviation 0.71
|
-0.9 units on a scale
Standard Deviation 0.85
|
-0.8 units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Abdominal symptoms subscore
|
-0.8 units on a scale
Standard Deviation 0.85
|
-0.7 units on a scale
Standard Deviation 0.97
|
-0.7 units on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Rectal symptoms subscore
|
-0.7 units on a scale
Standard Deviation 0.84
|
-0.7 units on a scale
Standard Deviation 0.84
|
-0.6 units on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Stool symptoms subscore
|
-1.2 units on a scale
Standard Deviation 0.90
|
-1.1 units on a scale
Standard Deviation 1.04
|
-0.9 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)Population: The modified intent-to-treat (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 N denotes the number of patients with a baseline and last on-treatment value.
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=84 Participants
NKTR-118 12.5 mg QD, oral treatment
|
NKTR-118 25 mg
n=89 Participants
NKTR-118 25 mg QD, oral treatment
|
Placebo
n=96 Participants
Placebo QD, oral treatment
|
|---|---|---|---|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Total score
|
-1.0 units on a scale
Standard Deviation 0.89
|
-0.9 units on a scale
Standard Deviation 0.82
|
-0.8 units on a scale
Standard Deviation 0.74
|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Physical discomfort
|
-1.0 units on a scale
Standard Deviation 0.97
|
-1.1 units on a scale
Standard Deviation 0.97
|
-1.0 units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Psychosocial discomfort
|
-0.8 units on a scale
Standard Deviation 0.97
|
-0.7 units on a scale
Standard Deviation 0.86
|
-0.6 units on a scale
Standard Deviation 0.81
|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Worries/concerns
|
-1.0 units on a scale
Standard Deviation 1.09
|
-0.9 units on a scale
Standard Deviation 0.91
|
-0.7 units on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Satisfaction
|
-1.2 units on a scale
Standard Deviation 1.14
|
-1.3 units on a scale
Standard Deviation 1.22
|
-1.1 units on a scale
Standard Deviation 1.21
|
Adverse Events
NKTR-118 12.5 mg
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
NKTR-118 25 mg
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NKTR-118 12.5 mg
n=94 participants at risk
|
NKTR-118 25 mg
n=97 participants at risk
|
Placebo
n=100 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
URINARY TRACT INFECTION FUNGAL
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Investigations
BLOOD PRESSURE INCREASED
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Renal and urinary disorders
DYSURIA
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILU RE
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
Other adverse events
| Measure |
NKTR-118 12.5 mg
n=94 participants at risk
|
NKTR-118 25 mg
n=97 participants at risk
|
Placebo
n=100 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.1%
2/94 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
3.1%
3/97 • Number of events 3
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.3%
4/94 • Number of events 4
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Gastrointestinal disorders
NAUSEA
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
3.1%
3/97 • Number of events 3
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.0%
2/100 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
General disorders
LOCAL SWELLING
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
BRONCHITIS
|
2.1%
2/94 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
3.1%
3/97 • Number of events 3
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
SINUSITIS
|
4.3%
4/94 • Number of events 4
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/97 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.1%
2/94 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.1%
1/94 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
3.0%
3/100 • Number of events 3
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
3.1%
3/97 • Number of events 3
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Investigations
BLOOD TESTOSTERONE DECREASED
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
6.2%
6/97 • Number of events 6
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
3.1%
3/97 • Number of events 3
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
1.0%
1/100 • Number of events 1
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
3.0%
3/100 • Number of events 3
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.0%
2/100 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Psychiatric disorders
DEPRESSION
|
2.1%
2/94 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/97
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/94
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
2.1%
2/97 • Number of events 2
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
0.00%
0/100
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60