Trial Outcomes & Findings for Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer (NCT NCT03087708)
NCT ID: NCT03087708
Last Updated: 2025-07-17
Results Overview
Calculated as the total number of patients accrued to the study over two years divided by 184, the total expected accrual of patients evaluable for the primary endpoint.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
Group I (Lower Dose Naloxegol, Placebo)
Patients receive lower dose naloxegol PO QD and placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\> \> Naloxegol: Given PO\>
\> Placebo: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
Group II (Placebo, Higher Dose Naloxegol)
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\> \> Naloxegol: Given PO\>
\> Placebo: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>
\> Placebo: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Group I (Lower Dose Naloxegol, Placebo)
n=15 Participants
Patients receive lower dose naloxegol PO QD and placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group II (Placebo, Higher Dose Naloxegol)
n=15 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=13 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=5 Participants
|
67.0 years
n=7 Participants
|
62.0 years
n=5 Participants
|
66.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
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 (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Planned use of Bevacizumab
No
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Planned use of Bevacizumab
Yes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
ECOG Performance Score
0-1
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
ECOG Performance Score
2
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Pathologic T Stage
T0
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Pathologic T Stage
T1a
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Pathologic T Stage
T1b
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Pathologic T Stage
T2a
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Pathologic T Stage
T2b
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Pathologic T Stage
T3a
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Pathologic T Stage
T3b
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Pathologic T Stage
T4
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Pathologic T Stage
Tx
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Smoking Status
Current smoker
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Smoking Status
Former smoker (no smoking for one year or more)
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Smoking Status
Never smoked (less than 100 cigarettes in lifetime)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsCalculated as the total number of patients accrued to the study over two years divided by 184, the total expected accrual of patients evaluable for the primary endpoint.
Outcome measures
| Measure |
Expected Accrued Patients
n=184 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Observed Accrual Rate Defined as Rate of Accrual Remaining >= 80% of the Expected
|
0.272 proportion of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 monthsThe proportion of patients alive at 6 months who continue study drug and complete the health-related quality of life and other forms for at least 6 months will be calculated by arm.
Outcome measures
| Measure |
Expected Accrued Patients
n=15 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=15 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=13 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Proportion of Patients Alive Who Continue Study Drug and Complete the Health-related Quality of Life and Other Forms
|
0.4667 Ratio of patients evaluable for endpoint
Interval 0.2127 to 0.7341
|
0.4667 Ratio of patients evaluable for endpoint
Interval 0.2127 to 0.7341
|
0.3846 Ratio of patients evaluable for endpoint
Interval 0.1386 to 0.6842
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe frequency of adverse events will be summarized by arm and compared between each treatment arm vs the placebo arm using Fisher's exact test. \<3 is better and 3+ is worse.
Outcome measures
| Measure |
Expected Accrued Patients
n=15 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=15 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=13 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Hematologic Adverse Events (regardless of attribution) : 3+
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Hematologic Adverse Events (regardless of attribution) : <3
|
11 Participants
|
12 Participants
|
11 Participants
|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Non-Hematologic Adverse Events (regardless of attribution) : 3+
|
9 Participants
|
9 Participants
|
6 Participants
|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Non-Hematologic Adverse Events (regardless of attribution) : <3
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Hematologic Adverse Events (at least possibly related to study) : 3+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Hematologic Adverse Events (at least possibly related to study) : <3
|
14 Participants
|
15 Participants
|
13 Participants
|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Non-Hematologic Adverse Events (at least possibly related to study) : 3+
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Incidence of Adverse Events as Described and Graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0
Non-Hematologic Adverse Events (at least possibly related to study) : <3
|
14 Participants
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsHealth-related quality of life scores at each timepoint and changes in scores between 6 months and baseline will be summarized by mean standard deviation, median (inter-quartile range). Scores will be plotted to explore the pattern over time and to examine differences between treatment arms. Differences in health-related quality of life between the treatment arms and the placebo arm will be conducted through linear mixed models and growth curve models to account for repeated assessments. Trial outcome index score is 0-92 with 0 being the worst and 92 being the best.
Outcome measures
| Measure |
Expected Accrued Patients
n=7 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=7 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=5 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Change in Trial Outcome Index
|
21.0 units on a scale
Interval 0.0 to 27.0
|
14.0 units on a scale
Interval -4.0 to 20.0
|
9.0 units on a scale
Interval -1.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Two patients on the Naloxegol 12.5 mg arm did not complete all of the questions for the Fact-L at 6 months.
Health-related quality of life scores at each timepoint and changes in scores between 6 months and baseline will be summarized by mean standard deviation, median (inter-quartile range). Scores will be plotted to explore the pattern over time and to examine differences between treatment arms. Differences in health-related quality of life between the treatment arms and the placebo arm will be conducted through linear mixed models and growth curve models to account for repeated assessments. Function subscales score is 0-28 with 0 being the worst and 28 being the best.
Outcome measures
| Measure |
Expected Accrued Patients
n=7 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=7 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=5 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Change in Function Subscales
Functional Well Being
|
6.5 units on a scale
Interval 2.0 to 8.0
|
5.0 units on a scale
Interval -3.0 to 10.0
|
4.0 units on a scale
Interval 3.0 to 6.0
|
|
Change in Function Subscales
Physical Well Being
|
4.7 units on a scale
Interval 3.0 to 8.0
|
0.0 units on a scale
Interval -3.0 to 3.0
|
-0.3 units on a scale
Interval -5.8 to 0.0
|
|
Change in Function Subscales
Social Function Well Being
|
6.0 units on a scale
Interval -3.0 to 9.0
|
5.0 units on a scale
Interval -2.0 to 7.0
|
-2 units on a scale
Interval -3.0 to 1.0
|
|
Change in Function Subscales
Emotional Well Being
|
2.5 units on a scale
Interval 1.0 to 4.0
|
3.0 units on a scale
Interval 0.0 to 7.0
|
0 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Two patients on the Naloxegol 12.5 mg arm did not complete all of the questions for the Fact-L at 6 months.
Health-related quality of life scores at each timepoint and changes in scores between 6 months and baseline will be summarized by mean standard deviation, median (inter-quartile range). Scores will be plotted to explore the pattern over time and to examine differences between treatment arms. Differences in health-related quality of life between the treatment arms and the placebo arm will be conducted through linear mixed models and growth curve models to account for repeated assessments. Lung cancer subscale score is 0-36 with 0 being the worst and 36 being the best.
Outcome measures
| Measure |
Expected Accrued Patients
n=6 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=7 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=5 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Change in Lung Cancer Subscale of the Functional Assessment of Cancer Therapy-Lung
|
6.0 units on a scale
Interval -3.0 to 11.0
|
1.0 units on a scale
Interval 0.0 to 6.0
|
1.0 units on a scale
Interval -2.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPatient-Reported Outcome-Common Terminology Criteria for Adverse Events items will be summarized by arm. Patient-Reported Outcome-Common Terminology Criteria for Adverse Events response will be compared between the treatment arms vs. placebo arm using a chi-square test or Fisher's exact test as appropriate. Chosen PRO-CTCAE question is "In the last 7 days, what was the SEVERITY of your PAIN IN THE ABDOMEN (BELLY AREA) at its WORST?"
Outcome measures
| Measure |
Expected Accrued Patients
n=7 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=7 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=5 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Patient-reported Outcome Assessed by Patient-Reported Outcome-Common Terminology Criteria for Adverse Events
None
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Patient-reported Outcome Assessed by Patient-Reported Outcome-Common Terminology Criteria for Adverse Events
Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Patient-reported Outcome Assessed by Patient-Reported Outcome-Common Terminology Criteria for Adverse Events
Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Patient-reported Outcome Assessed by Patient-Reported Outcome-Common Terminology Criteria for Adverse Events
Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsLinear Analogue Self-Assessment items will be summarized by arm. Linear Analogue Self-Assessment scores will be compared between treatment arms versus placebo arm using Wilcoxon test. Linear Analogue Self-Assessment score is 0-10, with 0 being no trouble with ability to urinate easily and 10 being worst trouble with ability to urinate easily.
Outcome measures
| Measure |
Expected Accrued Patients
n=7 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=7 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=5 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Patient-reported Outcome Assessed by a Urinary Retention Linear Analogue Self-Assessment
|
0.0 units on a scale
Interval 0.0 to 0.0
|
0.0 units on a scale
Interval -3.0 to 0.0
|
0.0 units on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsOpioid-induced constipation rating scale will be summarized by arm. Scores will be compared between treatment arms vs. placebo arm using Wilcoxon test. Question from Bowel Function Diary is "In the past 24 hours, how much pain did you feel in your abdomen because of constipation?". Opioid-induced constipation rating scale is from 0-6, with 0 being none and 6 being very severe.
Outcome measures
| Measure |
Expected Accrued Patients
n=7 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=7 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=5 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Opioid-induced Constipation Rating Scale
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Only 19 patients completed the primary endpoint of staying on treatment and completing QOL booklets for 6 months.
Pain scores will be summarized by arm. Pain scores will be compared between treatment arms vs. placebo using Wilcoxon test. Pain score scale is 0-10, with 10 being worst pain imaginable
Outcome measures
| Measure |
Expected Accrued Patients
n=15 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=13 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=12 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Level of Pain
Average Pain Scores at Baseline (
|
6.5 units on a scale
Interval 5.0 to 8.0
|
5.0 units on a scale
Interval 1.0 to 7.0
|
4.5 units on a scale
Interval 4.0 to 7.0
|
|
Level of Pain
Average Pain Scores at 6 Months
|
0.0 units on a scale
Interval 0.0 to 7.0
|
3.7 units on a scale
Interval 0.0 to 6.0
|
2.2 units on a scale
Interval 0.0 to 5.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only 19 patients completed the primary endpoint of staying on treatment and completing QOL booklets for 6 months.
The protocol-defined analysis for this secondary endpoint was not performed due to not specifying analgesic use in the questionnaire. Analgesic use will be summarized by arm. Frequencies of analgesic used will be compared using chi-square test or Fisher's exact test, as appropriate.
Outcome measures
| Measure |
Expected Accrued Patients
n=15 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=13 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=12 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Analgesic Use
Analgesic use at Baseline? · Yes
|
13 Participants
|
10 Participants
|
11 Participants
|
|
Analgesic Use
Analgesic use at Baseline? · No
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Analgesic Use
Analgesic use at Baseline? · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Analgesic Use
Analgesic Use at 6 Months? · Yes
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Analgesic Use
Analgesic Use at 6 Months? · No
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Analgesic Use
Analgesic Use at 6 Months? · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsA Fisher's exact test was not performed due to low sample size. Frequency of discontinuation of chemotherapy will be summarized by arm and compared between each treatment arm vs the placebo arm using Fisher's exact test.
Outcome measures
| Measure |
Expected Accrued Patients
n=17 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=16 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=17 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Unexpected Clinical Outcomes With Chemotherapy
Treatment (Intervention) Completed Per Protocol Criteria
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Unexpected Clinical Outcomes With Chemotherapy
Patient Withdrawal/Refusal After Beginning Protocol Therapy (Intervention)
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Unexpected Clinical Outcomes With Chemotherapy
Adverse Events/Side Effects/Complications
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Unexpected Clinical Outcomes With Chemotherapy
Patient Off-Treatment (Intervention) For Other Complicating Disease
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Unexpected Clinical Outcomes With Chemotherapy
Death On Study
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Unexpected Clinical Outcomes With Chemotherapy
Other
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Unexpected Clinical Outcomes With Chemotherapy
Patient Withdrawal/Refusal Prior To Beginning Protocol Therapy (Intervention)
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Unexpected Clinical Outcomes With Chemotherapy
Missing
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to disease progression/relapse, death, or loss to follow-up, whichever occurs first, assessed up to 2 yearsProgression-free survival probabilities will be estimated by arm using the Kaplan-Meier estimator. In an exploratory manner, a Cox proportional hazards model will be used to determine the effect of naloxegol on progression-free survival.
Outcome measures
| Measure |
Expected Accrued Patients
n=15 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=15 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=13 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Progression-free Survival Assessed by Using the Standard Response Evaluation Criteria in Solid Tumors 1.1 Criteria
Censored
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Progression-free Survival Assessed by Using the Standard Response Evaluation Criteria in Solid Tumors 1.1 Criteria
Death
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Progression-free Survival Assessed by Using the Standard Response Evaluation Criteria in Solid Tumors 1.1 Criteria
Progression
|
2 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomization to death or loss to follow-up, whichever occurs first, assessed up to 2 yearsOverall survival probabilities will be estimated by arm using the Kaplan-Meier estimator. In an exploratory manner, a Cox proportional hazards model will be used to determine the effect of naloxegol on overall survival.
Outcome measures
| Measure |
Expected Accrued Patients
n=15 Participants
Expected accrued patients to be evaluable
|
Group II (Placebo, Higher Dose Naloxegol)
n=15 Participants
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\> \>\> Naloxegol: Given PO\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
Group III (Placebo)
n=13 Participants
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.\>\>
\>\> Placebo: Given PO\>\>
\>\> Laboratory Biomarker Analysis: Correlative studies\>\>
\>\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Overall Survival
Censored
|
9 Participants
|
6 Participants
|
7 Participants
|
|
Overall Survival
Death
|
6 Participants
|
9 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsThe protocol-defined analysis for this secondary endpoint was not performed due to being a correlative endpoint and not being collected in the data. MOR expression and activation will be included as a covariate in the linear mixed model, an interaction between MOR expression/activation and treatment will be evaluated.
Outcome measures
Outcome data not reported
Adverse Events
Group III (Placebo)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 6 deaths
Group II (Placebo, Higher Dose Naloxegol)
Serious events: 9 serious events
Other events: 11 other events
Deaths: 10 deaths
Group I (Lower Dose Naloxegol, Placebo)
Serious events: 9 serious events
Other events: 15 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Group III (Placebo)
n=14 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
Group II (Placebo, Higher Dose Naloxegol)
n=16 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
Group I (Lower Dose Naloxegol, Placebo)
n=15 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
12.5%
2/16 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Death NOS
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
18.8%
3/16 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Fatigue
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Fever
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Sudden death NOS
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Lung infection
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
Other adverse events
| Measure |
Group III (Placebo)
n=14 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
Group II (Placebo, Higher Dose Naloxegol)
n=16 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
Group I (Lower Dose Naloxegol, Placebo)
n=15 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
12.5%
2/16 • Number of events 14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
20.0%
3/15 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Eye disorders
Blurred vision
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Eye disorders
Eye pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Eye disorders
Watering eyes
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
6/14 • Number of events 20 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
37.5%
6/16 • Number of events 16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
26.7%
4/15 • Number of events 6 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 10 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 13 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Diarrhea
|
35.7%
5/14 • Number of events 10 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
25.0%
4/16 • Number of events 9 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
26.7%
4/15 • Number of events 11 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Dry mouth
|
42.9%
6/14 • Number of events 26 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
18.8%
3/16 • Number of events 27 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
46.7%
7/15 • Number of events 12 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Flatulence
|
28.6%
4/14 • Number of events 13 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
31.2%
5/16 • Number of events 15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
20.0%
3/15 • Number of events 9 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Nausea
|
64.3%
9/14 • Number of events 45 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
50.0%
8/16 • Number of events 24 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
66.7%
10/15 • Number of events 28 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Gastrointestinal disorders
Vomiting
|
35.7%
5/14 • Number of events 17 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
37.5%
6/16 • Number of events 13 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
46.7%
7/15 • Number of events 17 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Death NOS
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Edema limbs
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 4 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
20.0%
3/15 • Number of events 20 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Flu like symptoms
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
General disorders
Pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
12.5%
2/16 • Number of events 4 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
Platelet count decreased
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
Weight gain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
Weight loss
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Investigations
White blood cell decreased
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
25.0%
4/16 • Number of events 4 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
20.0%
3/15 • Number of events 5 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 12 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
12.5%
2/16 • Number of events 12 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 4 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
12.5%
2/16 • Number of events 6 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Number of events 10 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
18.8%
3/16 • Number of events 9 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
33.3%
5/15 • Number of events 12 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 5 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
20.0%
3/15 • Number of events 18 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 4 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 2 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
2/14 • Number of events 14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
12.5%
2/16 • Number of events 6 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
13.3%
2/15 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 3 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/16 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.7%
1/15 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
6.2%
1/16 • Number of events 1 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
0.00%
0/15 • 5 Years
For Group I (Lower Dose Naloxegol, Placebo), 2 patients withdrew prior to starting treatment and no AE data was collected. For Group III (Placebo), 3 patients withdrew prior to starting treatment and no AE data was collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place