Trial Outcomes & Findings for Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain (NCT NCT01307020)
NCT ID: NCT01307020
Last Updated: 2013-08-12
Results Overview
Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
745 participants
Primary outcome timeframe
6 hours
Results posted on
2013-08-12
Participant Flow
First patient in (screening) 23 Feb 2011, last patient out 14 Oct 2011. At 16 study centres in 6 European countries (Germany, Italy, Hungary, Poland, Spain and United Kingdom).
The trial encompassed 3 visits: 1-Screening; 2-Dental surgery (patients who have moderate to severe pain afterwards were randomised and received study drug); 3-End of study. Overall, 745 patients were enrolled (screened), of them 611 were randomized to receive the study drug and therefore considered as started.
Participant milestones
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
Placebo oral film-coated tablet, once
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
63
|
61
|
60
|
61
|
59
|
60
|
61
|
62
|
|
Overall Study
Safety Population
|
61
|
63
|
63
|
61
|
60
|
61
|
59
|
60
|
61
|
62
|
|
Overall Study
ITT (>= 1 Assessment Post Randomization)
|
60
|
62
|
63
|
61
|
60
|
60
|
59
|
59
|
60
|
62
|
|
Overall Study
COMPLETED
|
61
|
62
|
62
|
60
|
60
|
61
|
58
|
60
|
61
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
Placebo oral film-coated tablet, once
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Electronic data capture failure
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Baseline characteristics by cohort
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
n=61 Participants
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
n=63 Participants
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
n=63 Participants
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
n=61 Participants
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
n=60 Participants
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
n=61 Participants
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
n=59 Participants
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
n=60 Participants
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
n=61 Participants
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
n=62 Participants
Placebo oral film-coated tablet, once
|
Total
n=611 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
28.6 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 7.33 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 7.55 • n=4 Participants
|
27.0 years
STANDARD_DEVIATION 9.85 • n=21 Participants
|
26.9 years
STANDARD_DEVIATION 6.94 • n=8 Participants
|
25.5 years
STANDARD_DEVIATION 7.15 • n=8 Participants
|
27.8 years
STANDARD_DEVIATION 7.99 • n=24 Participants
|
26.6 years
STANDARD_DEVIATION 6.48 • n=42 Participants
|
26.1 years
STANDARD_DEVIATION 6.64 • n=42 Participants
|
26.9 years
STANDARD_DEVIATION 7.56 • n=42 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
41 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
364 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
247 Participants
n=42 Participants
|
|
BMI
|
23.7 kg/m^2
STANDARD_DEVIATION 3.39 • n=5 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 3.69 • n=7 Participants
|
23.0 kg/m^2
STANDARD_DEVIATION 2.87 • n=5 Participants
|
23.2 kg/m^2
STANDARD_DEVIATION 3.19 • n=4 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 3.20 • n=21 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 3.30 • n=8 Participants
|
23.0 kg/m^2
STANDARD_DEVIATION 3.19 • n=8 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 3.08 • n=24 Participants
|
22.4 kg/m^2
STANDARD_DEVIATION 3.04 • n=42 Participants
|
22.7 kg/m^2
STANDARD_DEVIATION 2.80 • n=42 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 3.21 • n=42 Participants
|
PRIMARY outcome
Timeframe: 6 hoursPopulation: ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment
Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %
Outcome measures
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
n=60 Participants
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
n=62 Participants
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
n=63 Participants
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
n=61 Participants
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
n=60 Participants
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
n=60 Participants
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
n=59 Participants
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
n=59 Participants
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
n=60 Participants
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
n=62 Participants
Placebo oral film-coated tablet, once
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.
|
36.7 percentage of patients
|
59.7 percentage of patients
|
55.6 percentage of patients
|
72.1 percentage of patients
|
26.7 percentage of patients
|
55.0 percentage of patients
|
10.2 percentage of patients
|
25.4 percentage of patients
|
45.0 percentage of patients
|
9.7 percentage of patients
|
SECONDARY outcome
Timeframe: 4, 8 and 12 hoursPopulation: ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment
Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %
Outcome measures
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
n=60 Participants
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
n=62 Participants
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
n=63 Participants
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
n=61 Participants
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
n=60 Participants
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
n=60 Participants
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
n=59 Participants
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
n=59 Participants
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
n=60 Participants
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
n=62 Participants
Placebo oral film-coated tablet, once
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.
at 4 hours post-dose
|
63.3 percentage of patient
|
72.6 percentage of patient
|
65.1 percentage of patient
|
78.7 percentage of patient
|
40.0 percentage of patient
|
65.0 percentage of patient
|
11.9 percentage of patient
|
23.7 percentage of patient
|
56.7 percentage of patient
|
6.5 percentage of patient
|
|
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.
at 8 hours post-dose
|
21.7 percentage of patient
|
48.4 percentage of patient
|
44.4 percentage of patient
|
54.1 percentage of patient
|
16.7 percentage of patient
|
31.7 percentage of patient
|
6.8 percentage of patient
|
20.3 percentage of patient
|
33.3 percentage of patient
|
6.5 percentage of patient
|
|
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.
at 12 hours post-dose
|
11.7 percentage of patient
|
35.5 percentage of patient
|
28.6 percentage of patient
|
37.7 percentage of patient
|
10.0 percentage of patient
|
13.3 percentage of patient
|
5.1 percentage of patient
|
15.3 percentage of patient
|
25.0 percentage of patient
|
6.5 percentage of patient
|
SECONDARY outcome
Timeframe: Baseline to 6 hoursPopulation: ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment
Percentage of patients using rescue medication at 6 hours post-dosing.
Outcome measures
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
n=60 Participants
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
n=62 Participants
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
n=63 Participants
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
n=61 Participants
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
n=60 Participants
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
n=60 Participants
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
n=59 Participants
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
n=59 Participants
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
n=60 Participants
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
n=62 Participants
Placebo oral film-coated tablet, once
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Using Rescue Medication at 6 Hours
|
66.7 percentage of patients
|
46.8 percentage of patients
|
39.7 percentage of patients
|
37.7 percentage of patients
|
65.0 percentage of patients
|
53.3 percentage of patients
|
69.5 percentage of patients
|
64.4 percentage of patients
|
48.3 percentage of patients
|
72.6 percentage of patients
|
Adverse Events
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
DKP-TRIS 12.5mg - TRAM.HCl 75mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
DKP-TRIS 25mg - TRAM.HCl 37.5mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
DKP-TRIS 25mg - TRAM.HCl 75mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
DKP-TRIS 12.5mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DKP-TRIS 25mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TRAM.HCl 37.5mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TRAM.HCl 75mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Ibuprofen 400mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
n=61 participants at risk
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
n=63 participants at risk
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
n=63 participants at risk
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
n=61 participants at risk
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
n=60 participants at risk
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
n=61 participants at risk
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
n=59 participants at risk
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
n=60 participants at risk
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
n=61 participants at risk
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
n=62 participants at risk
Placebo oral film-coated tablet, once
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/63 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/63 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/60 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/59 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.7%
1/60 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/62 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
Other adverse events
| Measure |
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg
n=61 participants at risk
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg - TRAM.HCl 75mg
n=63 participants at risk
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 37.5mg
n=63 participants at risk
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg - TRAM.HCl 75mg
n=61 participants at risk
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
|
DKP-TRIS 12.5mg
n=60 participants at risk
DKP-TRIS 12.5mg oral film-coated tablet, once
|
DKP-TRIS 25mg
n=61 participants at risk
DKP-TRIS 25mg oral film-coated tablet, once
|
TRAM.HCl 37.5mg
n=59 participants at risk
TRAM.HCl 37.5mg oral film-coated tablet, once
|
TRAM.HCl 75mg
n=60 participants at risk
TRAM.HCl 75mg oral film-coated tablet, once
|
Ibuprofen 400mg
n=61 participants at risk
Ibuprofen 400mg oral film-coated tablet, once
|
Placebo
n=62 participants at risk
Placebo oral film-coated tablet, once
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.6%
4/61 • Number of events 4 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
6.3%
4/63 • Number of events 4 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.6%
1/63 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
6.6%
4/61 • Number of events 4 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.3%
2/60 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.6%
1/61 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.7%
1/59 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
10.0%
6/60 • Number of events 7 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/62 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
3/61 • Number of events 4 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
6.3%
4/63 • Number of events 4 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
4.8%
3/63 • Number of events 3 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
8.2%
5/61 • Number of events 6 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/60 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.3%
2/61 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/59 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
8.3%
5/60 • Number of events 5 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.3%
2/61 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/62 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
|
Nervous system disorders
Dizziness
|
1.6%
1/61 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
7.9%
5/63 • Number of events 5 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.6%
1/63 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
4.9%
3/61 • Number of events 3 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/60 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.4%
2/59 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
6.7%
4/60 • Number of events 4 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.3%
2/61 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.6%
1/62 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
|
Nervous system disorders
Headache
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.6%
1/63 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.2%
2/63 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/60 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/61 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
5.1%
3/59 • Number of events 3 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.3%
2/60 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.6%
1/61 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/62 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
|
General disorders
Pyrexia
|
4.9%
3/61 • Number of events 3 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/63 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/63 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
4.9%
3/61 • Number of events 3 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/60 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
3.3%
2/61 • Number of events 2 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.7%
1/59 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
5.0%
3/60 • Number of events 3 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
1.6%
1/61 • Number of events 1 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
0.00%
0/62 • 10 ± 3 days
Analyzed for the Safety population (all patients who received study treatment)
|
Additional Information
Dr Angela Capriati, Corporate Clinical Research Director
Menarini Ricerche S.p.A.
Phone: +39 055 5680 9933
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting the results of this study for publication or presentation, the investigator will allow the Sponsor at least 60 days time to review and comment upon the publication manuscript. It is agreed, that the results of the study will not be submitted for presentation, abstract, poster exhibition, or publication by the investigator until the Sponsor has reviewed/commented and agreed to any publication.
- Publication restrictions are in place
Restriction type: OTHER