Trial Outcomes & Findings for Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar (NCT NCT02777970)
NCT ID: NCT02777970
Last Updated: 2021-03-24
Results Overview
TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6). The TOTPAR6 ranges from a minimum of 0 to a maximum of 24.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
654 participants
Primary outcome timeframe
6 hours post-dose
Results posted on
2021-03-24
Participant Flow
This study was conducted in 18 centers across 5 European countries: Hungary, Italy, Poland, Spain and the United Kingdom. The clinical phase of the study started on 28th April 2016 (first screened patient) and concluded on 14th February 2017 (last patient out).
A total of 792 patients were screened, of which 654 patients were randomized. One randomized patient was excluded from all the analysis populations, because of being younger than 18 years old. Prior to randomization, enrolled patients underwent a Screening period lasting up 2 weeks.
Participant milestones
| Measure |
Tramadol/Dexketoprofen
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
261
|
262
|
131
|
|
Overall Study
COMPLETED
|
260
|
261
|
131
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Tramadol/Dexketoprofen
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Baseline characteristics by cohort
| Measure |
Tramadol/Dexketoprofen
n=260 Participants
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 Participants
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 Participants
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
Total
n=653 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
27.1 years
STANDARD_DEVIATION 8.13 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 7.67 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 7.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
309 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
235 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
586 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or Afro-american
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Pain Intensity at Qualification
|
5.0 units on a scale
STANDARD_DEVIATION 1.19 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.12 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 1.10 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.14 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 hours post-dosePopulation: A total of 654 patients were randomized and received the study treatments, of these one underage patient, erroneously enrolled in the study, was excluded from all the analysis populations, therefore 653 patients constituted ITT population.
TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6). The TOTPAR6 ranges from a minimum of 0 to a maximum of 24.
Outcome measures
| Measure |
Tramadol/Dexketoprofen
n=260 Participants
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 Participants
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 Participants
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)
|
13.0 5-point Verbal Rating Scale
Standard Deviation 6.97
|
9.2 5-point Verbal Rating Scale
Standard Deviation 7.65
|
1.9 5-point Verbal Rating Scale
Standard Deviation 3.89
|
SECONDARY outcome
Timeframe: 8 hours post-dosePopulation: ITT population
Percentage of patients who achieved at least 50% of the maximum TOTPAR at 8 hours. In the present trial the achievable TOTPAR over 8 hours ranges between 0 and 32."
Outcome measures
| Measure |
Tramadol/Dexketoprofen
n=260 Participants
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 Participants
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 Participants
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
% of Patients Achieving 50% of Max TOTPAR
|
47.7 percentage of patients
|
35.5 percentage of patients
|
5.3 percentage of patients
|
SECONDARY outcome
Timeframe: 8 hours post-dosePopulation: ITT population
Percentage of patients who achieve at least 30% of PI Reduction versus baseline Over 8 Hours Post-dose. Percentage change of PI is calculated using the baseline value minus the PI assessed at 8 hours post-dose divided for the baseline value, then multiplied for 100.
Outcome measures
| Measure |
Tramadol/Dexketoprofen
n=260 Participants
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 Participants
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 Participants
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
% of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose
|
40.0 percentage of patients
|
35.5 percentage of patients
|
9.9 percentage of patients
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The analysis is conducted only on active treatment arms.
Time to confirmed FPPAR (time to onset of analgesia) - i.e. time to FPPAR if confirmed by experiencing Meaningful Pain Relief (MPAR) FPPAR and MPAR assessed by using stopwatches: 1. 'first perceptible' PAR (FPPAR), i.e, at the moment they first felt any PAR whatsoever; 2. 'meaningful' PAR (MPAR, ie, when the relief from pain became meaningful to them)
Outcome measures
| Measure |
Tramadol/Dexketoprofen
n=260 Participants
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 Participants
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
Time to Confirmed FPPAR (First Perceptible Pain Relief)
|
21 minutes
Interval 17.0 to 23.0
|
24 minutes
Interval 20.0 to 27.0
|
—
|
SECONDARY outcome
Timeframe: 8 hours post-dosePopulation: ITT population
Percentage of patients who required RM within the first over 8 hours post-dose.
Outcome measures
| Measure |
Tramadol/Dexketoprofen
n=260 Participants
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 Participants
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 Participants
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
% of Patients Requiring RM (Rescue Medication)
|
51.2 percentage of patients
|
55.0 percentage of patients
|
88.5 percentage of patients
|
SECONDARY outcome
Timeframe: 8 hours postdosePopulation: ITT population
PGE of the study medication (measured according to a five-point VRS from 1 = poor to 5 = excellent) at 8 hours post-dose or whenever the patient uses Rescue Medication (RM).
Outcome measures
| Measure |
Tramadol/Dexketoprofen
n=260 Participants
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 Participants
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 Participants
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
PGE (Patient Global Evaluation)
|
3.6 units on a scale
Standard Deviation 1.1
|
2.8 units on a scale
Standard Deviation 1.4
|
1.5 units on a scale
Standard Deviation 0.9
|
Adverse Events
Tramadol/Dexketoprofen
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Tramadol/Paracetamol
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tramadol/Dexketoprofen
n=260 participants at risk
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 participants at risk
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 participants at risk
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.38%
1/260 • Number of events 1 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.00%
0/262 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.00%
0/131 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
Other adverse events
| Measure |
Tramadol/Dexketoprofen
n=260 participants at risk
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
|
Tramadol/Paracetamol
n=262 participants at risk
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
|
Placebo
n=131 participants at risk
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.8%
10/260 • Number of events 10 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
4.2%
11/262 • Number of events 11 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.00%
0/131 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
11/260 • Number of events 11 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
5.3%
14/262 • Number of events 14 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.00%
0/131 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
|
General disorders
Face oedema
|
1.2%
3/260 • Number of events 3 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
3.1%
8/262 • Number of events 8 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
3.1%
4/131 • Number of events 4 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
|
Nervous system disorders
Dizziness
|
2.3%
6/260 • Number of events 6 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
5.0%
13/262 • Number of events 13 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.00%
0/131 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
|
Nervous system disorders
Somnolence
|
2.7%
7/260 • Number of events 7 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
1.5%
4/262 • Number of events 4 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.76%
1/131 • Number of events 1 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
|
Infections and infestations
Postoperative wound infection
|
3.1%
8/260 • Number of events 8 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.76%
2/262 • Number of events 2 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
1.5%
2/131 • Number of events 2 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.2%
3/260 • Number of events 3 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
1.9%
5/262 • Number of events 5 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
2.3%
3/131 • Number of events 3 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
|
Vascular disorders
Haematoma
|
0.77%
2/260 • Number of events 2 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
0.00%
0/262 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
2.3%
3/131 • Number of events 3 • Reported treatment emergent AEs (TEAEs) include events starting after administration of study drug on or after Day 1 and on or before end of study visit Day 6+/- 1.
If an AE occurs for the first time or if it worsens after study drug intake it is classified as TEAE. If a subject experienced more than 1 of a given TEAE, the subject is counted only once for that TEAE. Overall 654 patients received the treatment, however one patient was excluded from all the analysis populations, because of being younger than 18 years old. Thus, the safety population accounts for 653 patients.
|
Additional Information
Dr. Angela Capriati (Clinical Sciences Director)
Menarini Ricerche
Phone: +39 055 5680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place