Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine (NCT NCT00505414)
NCT ID: NCT00505414
Last Updated: 2019-11-01
Results Overview
A "responder" is a participant in the study that: 1. completed 28 days of the maintenance phase 2. had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43. 3. did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43). A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
End of the 4 week Maintenance Phase (Day 43)
Results posted on
2019-11-01
Participant Flow
First participant in was enrolled on 29 June 2007 and the Last participant out was on the 02 February 2009. In general this was an out-patient study subject to country specific regulations.
Eligible participants were required to stop their previous analgesic \[pain treatment\] therapy at randomization. 136 participants consented. 43 participants were not eligible for randomization to tapentadol extended release or morphine controlled release at baseline. 93 participants started the titration period.
Participant milestones
| Measure |
Morphine (Maintenance Phase)
Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
|
Tapentadol (Maintenance Phase)
Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
|
Matching Placebo (Maintenance Phase)
Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
|
Tapentadol (Titration Phase)
After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg up to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Morphine (Titration Phase)
After signing informed consent eligible participants were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
|---|---|---|---|---|---|
|
Titration Phase
STARTED
|
0
|
0
|
0
|
62
|
31
|
|
Titration Phase
COMPLETED
|
0
|
0
|
0
|
32
|
19
|
|
Titration Phase
NOT COMPLETED
|
0
|
0
|
0
|
30
|
12
|
|
Maintenance Phase
STARTED
|
18
|
15
|
14
|
0
|
0
|
|
Maintenance Phase
Did Not Qualify for Maintenance Phase
|
0
|
0
|
0
|
3
|
1
|
|
Maintenance Phase
COMPLETED
|
12
|
10
|
6
|
0
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
6
|
5
|
8
|
0
|
0
|
Reasons for withdrawal
| Measure |
Morphine (Maintenance Phase)
Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
|
Tapentadol (Maintenance Phase)
Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
|
Matching Placebo (Maintenance Phase)
Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
|
Tapentadol (Titration Phase)
After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg up to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Morphine (Titration Phase)
After signing informed consent eligible participants were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
|---|---|---|---|---|---|
|
Titration Phase
Adverse Event
|
0
|
0
|
0
|
8
|
3
|
|
Titration Phase
Death
|
0
|
0
|
0
|
2
|
0
|
|
Titration Phase
Lack of Efficacy
|
0
|
0
|
0
|
10
|
1
|
|
Titration Phase
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Titration Phase
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
4
|
|
Titration Phase
Underlying disease and therapy required
|
0
|
0
|
0
|
7
|
3
|
|
Maintenance Phase
Adverse Event
|
2
|
2
|
3
|
0
|
0
|
|
Maintenance Phase
Death
|
2
|
0
|
1
|
0
|
0
|
|
Maintenance Phase
Lack of Efficacy
|
2
|
1
|
1
|
0
|
0
|
|
Maintenance Phase
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Phase
underlying disease and therapy required
|
0
|
2
|
2
|
0
|
0
|
Baseline Characteristics
Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
Baseline characteristics by cohort
| Measure |
Tapentadol (Titration Phase)
n=62 Participants
After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Morphine (Titration Phase)
n=31 Participants
After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Titration Phase
|
62.4 years
STANDARD_DEVIATION 12.51 • n=62 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
60.6 years
STANDARD_DEVIATION 11.77 • n=31 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
61.8 years
STANDARD_DEVIATION 12.23 • n=93 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
|
Age, Continuous
Tapentadol Maintenance
|
63.5 years
STANDARD_DEVIATION 9.34 • n=15 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
—
|
63.5 years
STANDARD_DEVIATION 9.34 • n=15 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
|
Age, Continuous
Placebo Maintenance
|
61.0 years
STANDARD_DEVIATION 12.93 • n=14 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
—
|
61.0 years
STANDARD_DEVIATION 12.93 • n=14 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
|
Age, Continuous
Morphine Maintenance
|
—
|
58.4 years
STANDARD_DEVIATION 12.65 • n=18 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
58.4 years
STANDARD_DEVIATION 12.65 • n=18 Participants • Not all participants of the titration phase participated in the maintenance phase. The tapentadol titration population was subject to a randomized withdrawal-trial design in the maintenance phase and received either tapentadol or placebo.
|
|
Sex/Gender, Customized
Female (Titration)
|
35 participants
n=62 Participants
|
12 participants
n=31 Participants
|
47 participants
n=93 Participants
|
|
Sex/Gender, Customized
Male (Titration)
|
27 participants
n=62 Participants
|
19 participants
n=31 Participants
|
46 participants
n=93 Participants
|
|
Sex/Gender, Customized
Female (Morphine (Maintenance)
|
0 participants
n=62 Participants
|
8 participants
n=31 Participants
|
8 participants
n=93 Participants
|
|
Sex/Gender, Customized
Male (Morphine Maintenance)
|
0 participants
n=62 Participants
|
10 participants
n=31 Participants
|
10 participants
n=93 Participants
|
|
Sex/Gender, Customized
Female (Tapentadol Maintenance)
|
9 participants
n=62 Participants
|
0 participants
n=31 Participants
|
9 participants
n=93 Participants
|
|
Sex/Gender, Customized
Male (Tapentadol Maintenance)
|
6 participants
n=62 Participants
|
0 participants
n=31 Participants
|
6 participants
n=93 Participants
|
|
Sex/Gender, Customized
Female (Placebo Maintenance)
|
8 participants
n=62 Participants
|
0 participants
n=31 Participants
|
8 participants
n=93 Participants
|
|
Sex/Gender, Customized
Male (Placebo Maintenance)
|
6 participants
n=62 Participants
|
0 participants
n=31 Participants
|
6 participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=62 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=62 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=62 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=62 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=62 Participants
|
19 Participants
n=31 Participants
|
60 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=62 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=62 Participants
|
11 Participants
n=31 Participants
|
32 Participants
n=93 Participants
|
|
Region of Enrollment
France
|
5 participants
n=62 Participants
|
0 participants
n=31 Participants
|
5 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=62 Participants
|
4 participants
n=31 Participants
|
7 participants
n=93 Participants
|
|
Region of Enrollment
Argentina
|
14 participants
n=62 Participants
|
7 participants
n=31 Participants
|
21 participants
n=93 Participants
|
|
Region of Enrollment
Ukraine
|
16 participants
n=62 Participants
|
5 participants
n=31 Participants
|
21 participants
n=93 Participants
|
|
Region of Enrollment
Chile
|
18 participants
n=62 Participants
|
9 participants
n=31 Participants
|
27 participants
n=93 Participants
|
|
Region of Enrollment
Latvia
|
6 participants
n=62 Participants
|
6 participants
n=31 Participants
|
12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: End of the 4 week Maintenance Phase (Day 43)Population: Full Analysis Set. Number of participants with data available.
A "responder" is a participant in the study that: 1. completed 28 days of the maintenance phase 2. had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43. 3. did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43). A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder.
Outcome measures
| Measure |
Morphine (Maintenance Phase)
n=18 Participants
Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
|
Tapentadol (Maintenance Phase)
n=15 Participants
Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
|
Matching Placebo (Maintenance Phase)
n=14 Participants
Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
|
Tapentadol (Titration Phase)
After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Morphine (Titration Phase)
After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
|---|---|---|---|---|---|
|
Responder Rates in Maintenance Period
|
6 participants
|
8 participants
|
3 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 corresponds with PGIC at end of titration phase; Day 43 corresponds with PGIC at end of maintenance phasePopulation: Full Analysis Set. Number of participants with data available.
The Patient Global Impression of Change (PGIC) is an instrument where the participant indicates their perceived change at the end of a treatment phase. The overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in tapentadol and morphine at Day 15 (Start of Maintenance Phase) and repeated in participants completing the Maintenance Phase in the Matching Placebo, Tapentadol and Morphine (Day 43).
Outcome measures
| Measure |
Morphine (Maintenance Phase)
n=18 Participants
Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
|
Tapentadol (Maintenance Phase)
n=15 Participants
Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
|
Matching Placebo (Maintenance Phase)
n=14 Participants
Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
|
Tapentadol (Titration Phase)
n=62 Participants
After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Morphine (Titration Phase)
n=31 Participants
After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
|---|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
Very Much Improved
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Patient Global Impression of Change (PGIC)
Much Improved
|
3 participants
|
8 participants
|
2 participants
|
5 participants
|
1 participants
|
|
Patient Global Impression of Change (PGIC)
Minimally Improved
|
4 participants
|
4 participants
|
4 participants
|
8 participants
|
4 participants
|
|
Patient Global Impression of Change (PGIC)
No Change
|
4 participants
|
1 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Patient Global Impression of Change (PGIC)
Minimally Worse
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Patient Global Impression of Change (PGIC)
Much Worse
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Patient Global Impression of Change (PGIC)
Very Much Worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Patient Global Impression of Change (PGIC)
Missing
|
5 participants
|
0 participants
|
5 participants
|
40 participants
|
24 participants
|
Adverse Events
Morphine (Maintenance Phase)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Tapentadol (Maintenance Phase)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Matching Placebo (Maintenance Phase)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Tapentadol (Titration Phase)
Serious events: 11 serious events
Other events: 28 other events
Deaths: 0 deaths
Morphine (Titration Phase)
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Morphine (Maintenance Phase)
n=18 participants at risk
Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
|
Tapentadol (Maintenance Phase)
n=15 participants at risk
Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
|
Matching Placebo (Maintenance Phase)
n=14 participants at risk
Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
|
Tapentadol (Titration Phase)
n=62 participants at risk
After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Morphine (Titration Phase)
n=31 participants at risk
After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Asthenia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Chest Pain
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Death
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
2/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Infections and infestations
Pyelonephritis
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
13.3%
2/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
14.3%
2/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
4.8%
3/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Psychiatric disorders
Mental Status Change
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
Other adverse events
| Measure |
Morphine (Maintenance Phase)
n=18 participants at risk
Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
|
Tapentadol (Maintenance Phase)
n=15 participants at risk
Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
|
Matching Placebo (Maintenance Phase)
n=14 participants at risk
Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
|
Tapentadol (Titration Phase)
n=62 participants at risk
After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
Morphine (Titration Phase)
n=31 participants at risk
After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
2/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Asthenia
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
2/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
2/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Chills
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Renal and urinary disorders
Choluria
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
9.7%
6/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
9.7%
3/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
3/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
4/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Vascular disorders
Hypotension
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
14.3%
2/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
8.1%
5/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Lip Oedema
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
14.3%
2/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
11.3%
7/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
12.9%
4/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Oedema
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
4.8%
3/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
2/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
1.6%
1/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
9.7%
3/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
4.8%
3/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
2/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
General disorders
Thirst
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
1/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.7%
1/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
3.2%
2/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
4/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
0.00%
0/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
13.3%
2/15 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
7.1%
1/14 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
14.5%
9/62 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
6.5%
2/31 • Participants were to be treated for up to 42 days: Titration (14 days) and Maintenance Phase (up to 28 days).
More than one event might have occured in the same participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor and the Sponsor's designee reserves the right to review any publication pertaining to the trial at least 30 days before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.
- Publication restrictions are in place
Restriction type: OTHER