Trial Outcomes & Findings for Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain (NCT NCT01885182)
NCT ID: NCT01885182
Last Updated: 2019-10-04
Results Overview
BFI is the mean of NAS for the following items: * Ease of defecation * Feeling of incomplete bowel evacuation. * Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
232 participants
Primary outcome timeframe
Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study
Results posted on
2019-10-04
Participant Flow
The recruitment period is from 2013 Jun to 2014 Jul and the type of location is medical clinic.
There is no run-in period for this study.
Participant milestones
| Measure |
Oxycodone/Naloxone
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
115
|
|
Overall Study
Safety Population
|
114
|
111
|
|
Overall Study
FAP Population
|
107
|
106
|
|
Overall Study
COMPLETED
|
83
|
93
|
|
Overall Study
NOT COMPLETED
|
34
|
22
|
Reasons for withdrawal
| Measure |
Oxycodone/Naloxone
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
13
|
|
Overall Study
Withdrawal by Subject
|
13
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
8
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
60.0 years
STANDARD_DEVIATION 11.8 • n=106 Participants
|
58.8 years
STANDARD_DEVIATION 11.7 • n=213 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=107 Participants
|
45 Participants
n=106 Participants
|
97 Participants
n=213 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=107 Participants
|
61 Participants
n=106 Participants
|
116 Participants
n=213 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
107 participants
n=107 Participants
|
106 participants
n=106 Participants
|
213 participants
n=213 Participants
|
|
Body Mass Index (BMI)
|
21.9 kg/m2
STANDARD_DEVIATION 3.5 • n=107 Participants • one patient data was missing
|
21.7 kg/m2
STANDARD_DEVIATION 3.4 • n=105 Participants • one patient data was missing
|
21.8 kg/m2
STANDARD_DEVIATION 3.4 • n=212 Participants • one patient data was missing
|
PRIMARY outcome
Timeframe: Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from studyPopulation: below presents the mean BFI at final visit, primary analysis in FAP.
BFI is the mean of NAS for the following items: * Ease of defecation * Feeling of incomplete bowel evacuation. * Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Change of BFI-Bowel Function Index at visit8
|
48.3 score on BFI
Standard Deviation 25.7
|
51.2 score on BFI
Standard Deviation 26.4
|
PRIMARY outcome
Timeframe: Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from studyPopulation: FAP
Brief pain inventory short-form(BPI-SF) recorded at final visit assesses subject's average pain over the last 24 hours. score range is 0(no pain)-10(pain as bad as you can imagine).Do higher values represent a worse outcome.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Change of BPI-SF at visit8
|
3.7 Score on BPI-Brief Pain Index
Standard Deviation 1.7
|
3.6 Score on BPI-Brief Pain Index
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)Population: FAP
At Visit 5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)\*) for OXN PR and OXY PR groups.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8
Weekly number of bisacodyl taken at Visit5
|
2.1 laxatives/week
Standard Deviation 2.6
|
2.5 laxatives/week
Standard Deviation 2.6
|
|
The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8
Weekly number of bisacodyl taken at Visit8
|
2.2 laxatives/week
Standard Deviation 2.9
|
2.2 laxatives/week
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)Population: FAP
The average daily dose of rescue medication (Morphine Sulfate Tablet) for OXN PR group and OXY PR group at Visit 5(first week of double blind) and at Visit 8(last week of double blind).
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Change of Rescue Medication Use From visit5 to visit8
V5
|
18.5 Morphine Sulfate mg/day
Standard Deviation 21.4
|
13.9 Morphine Sulfate mg/day
Standard Deviation 18.9
|
|
The Change of Rescue Medication Use From visit5 to visit8
V8
|
15.4 Morphine Sulfate mg/day
Standard Deviation 22.1
|
15.5 Morphine Sulfate mg/day
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5)Population: FAP
to compare the Modified SOWS's Change from Visit 1(day-10-0) to Visit 3(day1),Change from Visit 1 to Visit 9(day35).The SOWS was scored as the total of the 15 symptoms. each symptoms score is 0(not at all)-4(extremely).total score range is 0-60.Do higher values represent a better outcome.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9
Change from Visit 1 to Visit 3
|
-1.2 score on SOWS
Standard Deviation 3.5
|
-1.6 score on SOWS
Standard Deviation 4.6
|
|
The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9
Change from Visit 1 to Visit 9
|
-1.3 score on SOWS
Standard Deviation 4.8
|
-1.7 score on SOWS
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study)Population: FAP
To assess quality of life based on EQ-5D by subjects evaluation via patient dairy.the quality of life based on EQ-5D at Visit1 (day-10-0) and end of treatment Visit8(day28). The scarc range is 0(the best state you can imagine)-100(the worst state you can imagine).Do higher values represent a worse outcome.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
To Assess Quality of Life Based on EQ-5D
V1
|
58.6 Score on EQ-5D
Standard Deviation 17.0
|
54.4 Score on EQ-5D
Standard Deviation 16.6
|
|
To Assess Quality of Life Based on EQ-5D
V8
|
59.0 Score on EQ-5D
Standard Deviation 19.3
|
53.9 Score on EQ-5D
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study)Population: FAP
To compare the change of Brief pain inventory short-form (BPI-SF) 11 indivial items (except for pain in average) at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28). each item range (except for how much relief from treatment /medication last 24hours is 0-100%,do higher values represent a better outcome.) is 0-10, do higher values represent a worse outcome.
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its worst last 24hrs-V2
|
5.9 score on BPI-SF
Standard Deviation 2.1
|
6.3 score on BPI-SF
Standard Deviation 2.1
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
How much relief from TRT/MED last 24hrs-visit8
|
64.7 score on BPI-SF
Standard Deviation 23.6
|
64.7 score on BPI-SF
Standard Deviation 24.2
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect general activity last 24hrs-visit2
|
5.6 score on BPI-SF
Standard Deviation 2.5
|
5.7 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect general activity last 24hrs-visit7
|
4.4 score on BPI-SF
Standard Deviation 2.6
|
4.8 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect general activity last 24hrs-visit8
|
4.6 score on BPI-SF
Standard Deviation 2.6
|
5.0 score on BPI-SF
Standard Deviation 2.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect normal work last 24hrs-visit5
|
5.6 score on BPI-SF
Standard Deviation 3.1
|
5.4 score on BPI-SF
Standard Deviation 2.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect normal work last 24hrs-visit8
|
5.0 score on BPI-SF
Standard Deviation 3.1
|
5.5 score on BPI-SF
Standard Deviation 3.2
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect relation with others last 24hrs-visit2
|
3.8 score on BPI-SF
Standard Deviation 2.8
|
4.1 score on BPI-SF
Standard Deviation 3.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect enjoyment of life last 24hrs-visit7
|
4.0 score on BPI-SF
Standard Deviation 2.8
|
4.8 score on BPI-SF
Standard Deviation 3.1
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its worst last 24hrs-V6
|
5.3 score on BPI-SF
Standard Deviation 2.3
|
5.2 score on BPI-SF
Standard Deviation 2.4
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its worst last 24hrs-V7
|
5.0 score on BPI-SF
Standard Deviation 2.1
|
5.0 score on BPI-SF
Standard Deviation 2.3
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its worst last 24hrs-V8
|
5.4 score on BPI-SF
Standard Deviation 2.2
|
5.2 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its least last 24hrs-V2
|
2.0 score on BPI-SF
Standard Deviation 1.5
|
2.1 score on BPI-SF
Standard Deviation 1.4
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its least last 24hrs-V5
|
3.4 score on BPI-SF
Standard Deviation 2.2
|
3.5 score on BPI-SF
Standard Deviation 1.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its least last 24hrs-V6
|
1.9 score on BPI-SF
Standard Deviation 1.5
|
1.9 score on BPI-SF
Standard Deviation 1.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its least last 24hrs-V7
|
2.1 score on BPI-SF
Standard Deviation 1.6
|
2.1 score on BPI-SF
Standard Deviation 1.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its least last 24hrs-V8
|
2.0 score on BPI-SF
Standard Deviation 1.6
|
2.2 score on BPI-SF
Standard Deviation 1.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate how much pain you have right now-visit2
|
3.4 score on BPI-SF
Standard Deviation 2.2
|
3.5 score on BPI-SF
Standard Deviation 1.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate how much pain you have right now-visit5
|
3.3 score on BPI-SF
Standard Deviation 2.0
|
3.3 score on BPI-SF
Standard Deviation 1.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate how much pain you have right now-visit6
|
3.1 score on BPI-SF
Standard Deviation 2.1
|
3.0 score on BPI-SF
Standard Deviation 1.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate how much pain you have right now-visit7
|
3.2 score on BPI-SF
Standard Deviation 1.9
|
3.1 score on BPI-SF
Standard Deviation 2.1
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate how much pain you have right now-visit8
|
3.2 score on BPI-SF
Standard Deviation 2.0
|
3.3 score on BPI-SF
Standard Deviation 2.1
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
How much relief from TRT/MED last 24hrs-visit2
|
67.3 score on BPI-SF
Standard Deviation 22.7
|
66.9 score on BPI-SF
Standard Deviation 19.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
How much relief from TRT/MED last 24hrs-visit5
|
67.7 score on BPI-SF
Standard Deviation 21.4
|
67.1 score on BPI-SF
Standard Deviation 21.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
How much relief from TRT/MED last 24hrs-visit6
|
67.6 score on BPI-SF
Standard Deviation 22.5
|
66.6 score on BPI-SF
Standard Deviation 21.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
How much relief from TRT/MED last 24hrs-visit7
|
64.1 score on BPI-SF
Standard Deviation 23.9
|
65.8 score on BPI-SF
Standard Deviation 21.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect general activity last 24hrs-visit5
|
4.6 score on BPI-SF
Standard Deviation 2.5
|
4.9 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect general activity last 24hrs-visit6
|
4.4 score on BPI-SF
Standard Deviation 2.6
|
4.9 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect mood last 24hrs-visit2
|
5.1 score on BPI-SF
Standard Deviation 2.7
|
5.6 score on BPI-SF
Standard Deviation 2.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect mood last 24hrs-visit5
|
4.6 score on BPI-SF
Standard Deviation 2.5
|
4.9 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect mood last 24hrs-visit6
|
4.1 score on BPI-SF
Standard Deviation 2.5
|
4.5 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect mood last 24hrs-visit7
|
3.8 score on BPI-SF
Standard Deviation 2.6
|
4.5 score on BPI-SF
Standard Deviation 2.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect mood last 24hrs-visit8
|
4.3 score on BPI-SF
Standard Deviation 2.5
|
4.5 score on BPI-SF
Standard Deviation 2.8
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect walking ability last 24hrs-visit2
|
4.3 score on BPI-SF
Standard Deviation 2.9
|
4.7 score on BPI-SF
Standard Deviation 3.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect walking ability last 24hrs-visit5
|
4.0 score on BPI-SF
Standard Deviation 3.0
|
4.1 score on BPI-SF
Standard Deviation 2.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect walking ability last 24hrs-visit6
|
3.6 score on BPI-SF
Standard Deviation 2.8
|
4.3 score on BPI-SF
Standard Deviation 3.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect walking ability last 24hrs-visit7
|
3.8 score on BPI-SF
Standard Deviation 2.8
|
4.4 score on BPI-SF
Standard Deviation 3.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Rate your pain at its worst last 24hrs-V5
|
5.4 score on BPI-SF
Standard Deviation 2.3
|
5.3 score on BPI-SF
Standard Deviation 2.3
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect walking ability last 24hrs-visit8
|
4.1 score on BPI-SF
Standard Deviation 2.9
|
4.6 score on BPI-SF
Standard Deviation 3.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect normal work last 24hrs-visit2
|
6.3 score on BPI-SF
Standard Deviation 3.1
|
6.5 score on BPI-SF
Standard Deviation 3.2
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect normal work last 24hrs-visit6
|
5.1 score on BPI-SF
Standard Deviation 3.1
|
5.6 score on BPI-SF
Standard Deviation 3.1
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect normal work last 24hrs-visit7
|
4.7 score on BPI-SF
Standard Deviation 3.0
|
5.4 score on BPI-SF
Standard Deviation 3.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect relation with others last 24hrs-visit5
|
3.5 score on BPI-SF
Standard Deviation 2.7
|
3.5 score on BPI-SF
Standard Deviation 2.6
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect relation with others last 24hrs-visit6
|
3.2 score on BPI-SF
Standard Deviation 2.6
|
3.6 score on BPI-SF
Standard Deviation 2.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect relation with others last 24hrs-visit7
|
3.2 score on BPI-SF
Standard Deviation 2.7
|
3.6 score on BPI-SF
Standard Deviation 2.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect relation with others last 24hrs-visit8
|
3.4 score on BPI-SF
Standard Deviation 2.6
|
4.0 score on BPI-SF
Standard Deviation 2.8
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect sleep last 24hrs-visit2
|
5.0 score on BPI-SF
Standard Deviation 2.9
|
5.1 score on BPI-SF
Standard Deviation 2.9
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect sleep last 24hrs-visit5
|
4.3 score on BPI-SF
Standard Deviation 2.7
|
4.1 score on BPI-SF
Standard Deviation 2.8
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect sleep last 24hrs-visit6
|
3.8 score on BPI-SF
Standard Deviation 2.5
|
3.9 score on BPI-SF
Standard Deviation 2.5
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect sleep last 24hrs-visit7
|
3.8 score on BPI-SF
Standard Deviation 2.6
|
3.9 score on BPI-SF
Standard Deviation 2.7
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect sleep last 24hrs-visit8
|
3.8 score on BPI-SF
Standard Deviation 2.6
|
4.1 score on BPI-SF
Standard Deviation 2.8
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect enjoyment of life last 24hrs-visit2
|
5.3 score on BPI-SF
Standard Deviation 3.2
|
5.7 score on BPI-SF
Standard Deviation 3.1
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect enjoyment of life last 24hrs-visit5
|
4.6 score on BPI-SF
Standard Deviation 3.0
|
4.6 score on BPI-SF
Standard Deviation 2.8
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect enjoyment of life last 24hrs-visit6
|
4.4 score on BPI-SF
Standard Deviation 3.0
|
4.7 score on BPI-SF
Standard Deviation 3.0
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Pain affect enjoyment of life last 24hrs-visit8
|
4.6 score on BPI-SF
Standard Deviation 2.9
|
4.9 score on BPI-SF
Standard Deviation 3.1
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Mean of seven interference items-visit2
|
5.0 score on BPI-SF
Standard Deviation 2.3
|
5.4 score on BPI-SF
Standard Deviation 2.4
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Mean of seven interference items-visit5
|
4.4 score on BPI-SF
Standard Deviation 2.2
|
4.4 score on BPI-SF
Standard Deviation 2.3
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Mean of seven interference items-visit6
|
4.1 score on BPI-SF
Standard Deviation 2.2
|
4.5 score on BPI-SF
Standard Deviation 2.4
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Mean of seven interference items-visit7
|
4.0 score on BPI-SF
Standard Deviation 2.2
|
4.5 score on BPI-SF
Standard Deviation 2.5
|
|
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
Mean of seven interference items-visit8
|
4.3 score on BPI-SF
Standard Deviation 2.4
|
4.7 score on BPI-SF
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study)Population: FAP
Number pf bowel movements(BM) and number of days the subjects had a bowel movement in the last 7 days before the study visit will be summarized at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28)..
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Change of Bowel Movement by Visit
Number of BM baseline in last 7 days-visit6
|
4.2 Bowel movement/day
Standard Deviation 3.4
|
3.9 Bowel movement/day
Standard Deviation 2.3
|
|
The Change of Bowel Movement by Visit
Number of BM baseline in last 7 days-visit7
|
4.2 Bowel movement/day
Standard Deviation 2.8
|
3.9 Bowel movement/day
Standard Deviation 2.3
|
|
The Change of Bowel Movement by Visit
Number of days with BM in last 7 days-visit2
|
2.8 Bowel movement/day
Standard Deviation 1.5
|
3.0 Bowel movement/day
Standard Deviation 1.6
|
|
The Change of Bowel Movement by Visit
Number of days with BM in last 7 days-visit5
|
3.1 Bowel movement/day
Standard Deviation 1.7
|
3.0 Bowel movement/day
Standard Deviation 1.6
|
|
The Change of Bowel Movement by Visit
Number of days with BM in last 7 days-visit6
|
3.4 Bowel movement/day
Standard Deviation 1.6
|
3.5 Bowel movement/day
Standard Deviation 1.7
|
|
The Change of Bowel Movement by Visit
Number of days with BM in last 7 days-visit7
|
3.6 Bowel movement/day
Standard Deviation 1.7
|
3.5 Bowel movement/day
Standard Deviation 1.8
|
|
The Change of Bowel Movement by Visit
Number of BM baseline in last 7 days-visit2
|
2.9 Bowel movement/day
Standard Deviation 1.7
|
3.1 Bowel movement/day
Standard Deviation 1.7
|
|
The Change of Bowel Movement by Visit
Number of BM baseline in last 7 days-visit5
|
3.7 Bowel movement/day
Standard Deviation 2.5
|
3.5 Bowel movement/day
Standard Deviation 2.6
|
|
The Change of Bowel Movement by Visit
Number of BM baseline in last 7 days-visit8
|
3.7 Bowel movement/day
Standard Deviation 2.5
|
3.5 Bowel movement/day
Standard Deviation 2.6
|
|
The Change of Bowel Movement by Visit
Number of days with BM in last 7 days-visit8
|
3.3 Bowel movement/day
Standard Deviation 1.8
|
3.2 Bowel movement/day
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicablePopulation: FAP
At Visit5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)\*) for OXN PR and OXY PR groups
Outcome measures
| Measure |
Oxycodone/Naloxone
n=107 Participants
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=106 Participants
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8
Daily number of bisacodyl taken at Visit5
|
0.9 laxatives/day
Standard Deviation 0.9
|
1.1 laxatives/day
Standard Deviation 0.9
|
|
The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8
Daily number of bisacodyl taken at Visit8
|
0.9 laxatives/day
Standard Deviation 0.9
|
0.9 laxatives/day
Standard Deviation 0.9
|
Adverse Events
Oxycodone/Naloxone
Serious events: 14 serious events
Other events: 72 other events
Deaths: 8 deaths
Oxycodone
Serious events: 12 serious events
Other events: 76 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Oxycodone/Naloxone
n=114 participants at risk
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=111 participants at risk
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
3.5%
4/114 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
2.7%
3/111 • Number of events 3 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
1.8%
2/114 • Number of events 2 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Ascites
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Bone marrow failure
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Nervous system disorders
Convulsion
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Social circumstances
Intentional overdose*
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Intra-abdominal hemorrhage
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Social circumstances
Suicide attempt
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Vascular disorders
Venous thrombosis
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.00%
0/111 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
Other adverse events
| Measure |
Oxycodone/Naloxone
n=114 participants at risk
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone/Naloxone
|
Oxycodone
n=111 participants at risk
5mg, 10mg, 20mg or 40mg
Oxycodone
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
23.7%
27/114 • Number of events 63 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
19.8%
22/111 • Number of events 57 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
6/114 • Number of events 17 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
5.4%
6/111 • Number of events 17 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Nausea
|
7.9%
9/114 • Number of events 13 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
10.8%
12/111 • Number of events 19 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
General disorders
Pyrexia
|
5.3%
6/114 • Number of events 8 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
5.4%
6/111 • Number of events 13 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
General disorders
Abdominal pain upper
|
0.88%
1/114 • Number of events 14 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
1.8%
2/111 • Number of events 5 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
General disorders
Fatigue
|
3.5%
4/114 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
8.1%
9/111 • Number of events 11 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
General disorders
Decreased appetite
|
1.8%
2/114 • Number of events 3 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
9.0%
10/111 • Number of events 10 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
General disorders
Dizziness
|
2.6%
3/114 • Number of events 3 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
5.4%
6/111 • Number of events 8 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
2/114 • Number of events 3 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
5.4%
6/111 • Number of events 8 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
6/114 • Number of events 6 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
3.6%
4/111 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Renal and urinary disorders
Urinary tract infection
|
3.5%
4/114 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
4.5%
5/111 • Number of events 5 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/114 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
5.4%
6/111 • Number of events 8 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
3.5%
4/114 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
2.7%
3/111 • Number of events 3 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Bone marrow failure
|
3.5%
4/114 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
1.8%
2/111 • Number of events 3 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
General disorders
Hyperhidrosis
|
1.8%
2/114 • Number of events 2 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
3.6%
4/111 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.6%
3/114 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
1.8%
2/111 • Number of events 2 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
3/114 • Number of events 5 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
0.90%
1/111 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
GGT increased
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
3.6%
4/111 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
|
General disorders
Somnolence
|
0.88%
1/114 • Number of events 1 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
3.6%
4/111 • Number of events 4 • The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.
same as clinicaltrials.gov definition
|
Additional Information
Clinical study manager
Mundipharma (China) Pharmaceutical Co. LTD
Phone: 0086-10-65636800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place