Trial Outcomes & Findings for A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain (NCT NCT02081391)
NCT ID: NCT02081391
Last Updated: 2020-01-18
Results Overview
The primary endpoint for the United States Food and Drug Administration (US FDA) (and secondary endpoint for the Pediatric Committee of the European Medicines Agency \[EU PDCO\]) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to \<18 years old) within 12 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
Up to 12 hours
Results posted on
2020-01-18
Participant Flow
The trial started on 19 Feb 2015 with the enrollment of the first participant. Recruitment of participants aged 2 to \<18 years old was completed on 05 Dec 2016 with the last participant out. Recruitment of the remaining participants aged from birth to \<2 years old was completed on 14 Mar 2019.
A total of 216 participants (or parents/caregivers) gave informed consent to participate in the trial, 180 of these participants were allocated to study drug (investigational medicinal product = IMP) and 175 participants received IMP (56 participants received placebo oral solution and 119 participants received tapentadol oral solution).
Participant milestones
| Measure |
Tapentadol (From 2 to <18 Years)
This arm includes all participants aged 2 years to less than 18 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA and who received at least 1 dose of tapentadol oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
Placebo (From 2 to <18 Years)
This arm includes all participants aged 2 years to less than 18 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA and who received at least 1 dose of placebo oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
Tapentadol (From Birth to <2 Years)
This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA and who received at least 1 dose of tapentadol oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
Placebo (From Birth to <2 Years)
This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA and who received at least 1 dose of placebo oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
|---|---|---|---|---|
|
12-hour Treatment
STARTED
|
108
|
52
|
11
|
4
|
|
12-hour Treatment
COMPLETED
|
90
|
46
|
10
|
4
|
|
12-hour Treatment
NOT COMPLETED
|
18
|
6
|
1
|
0
|
|
24-hour Treatment and Trial Completion
STARTED
|
90
|
46
|
10
|
4
|
|
24-hour Treatment and Trial Completion
COMPLETED
|
63
|
28
|
9
|
4
|
|
24-hour Treatment and Trial Completion
NOT COMPLETED
|
27
|
18
|
1
|
0
|
Reasons for withdrawal
| Measure |
Tapentadol (From 2 to <18 Years)
This arm includes all participants aged 2 years to less than 18 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA and who received at least 1 dose of tapentadol oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
Placebo (From 2 to <18 Years)
This arm includes all participants aged 2 years to less than 18 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA and who received at least 1 dose of placebo oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
Tapentadol (From Birth to <2 Years)
This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA and who received at least 1 dose of tapentadol oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
Placebo (From Birth to <2 Years)
This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA and who received at least 1 dose of placebo oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours. 24-hour treatment completers were defined as those who did not discontinue treatment before 24 hours; trial completers completed 24 hours of treatment and attended the follow up visit.
|
|---|---|---|---|---|
|
12-hour Treatment
Withdrawal by Subject
|
3
|
2
|
0
|
0
|
|
12-hour Treatment
Physician Decision
|
4
|
1
|
0
|
0
|
|
12-hour Treatment
Lack of Efficacy
|
3
|
0
|
0
|
0
|
|
12-hour Treatment
Adverse Event
|
4
|
2
|
0
|
0
|
|
12-hour Treatment
Recovery (opioid no longer needed)
|
2
|
0
|
1
|
0
|
|
12-hour Treatment
Further reasons
|
2
|
1
|
0
|
0
|
|
24-hour Treatment and Trial Completion
Physician Decision
|
10
|
5
|
0
|
0
|
|
24-hour Treatment and Trial Completion
Lack of Efficacy
|
1
|
3
|
0
|
0
|
|
24-hour Treatment and Trial Completion
Adverse Event
|
1
|
0
|
0
|
0
|
|
24-hour Treatment and Trial Completion
Recovery (opioid no longer needed)
|
11
|
5
|
1
|
0
|
|
24-hour Treatment and Trial Completion
Technical Problems
|
1
|
1
|
0
|
0
|
|
24-hour Treatment and Trial Completion
Further reasons
|
3
|
4
|
0
|
0
|
Baseline Characteristics
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
Baseline characteristics by cohort
| Measure |
Tapentadol (From 2 to <18 Years) - 12-h Treatm. Completion
n=108 Participants
Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA.
This arm includes all participants aged 2 years to less than 18 years who received at least 1 dose of tapentadol oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours.
|
Placebo (From 2 to <18 Years) - 12-h Treatm. Completion
n=52 Participants
Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA or PCA.
This arm includes all participants aged 2 years to less than 18 years who received at least 1 dose of placebo.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours.
|
Tapentadol (From Birth to <2 Years) - 12-h Treatm. Completion
n=11 Participants
Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA.
This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who received at least 1 dose of tapentadol oral solution.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours.
|
Placebo (From Birth to <2 Years) - 12-h Treatm. Completion
n=4 Participants
Participants had undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment via NCA.
This arm includes all participants aged from birth (at least 37 weeks gestational age) to less than 2 years who received at least 1 dose of placebo.
12-hour treatment period completers were defined as participants who did not discontinue the treatment period before 12 hours.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.8 years
n=5 Participants
|
10.4 years
n=7 Participants
|
0.74 years
n=5 Participants
|
0.48 years
n=4 Participants
|
9.81 years
n=21 Participants
|
|
Age, Customized
Children (2 to <12 years)
|
55 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Age, Customized
Adolescents (12 to <18 years)
|
53 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Age, Customized
Birth to less than 28 days
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Customized
28 days to less than 2 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
26 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
20 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
2 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Bulgaria
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Croatia
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Height
|
145 centimeter
n=5 Participants
|
143.3 centimeter
n=7 Participants
|
71.8 centimeter
n=5 Participants
|
65.3 centimeter
n=4 Participants
|
138.1 centimeter
n=21 Participants
|
|
Weight
|
43.09 kg
n=5 Participants
|
42.22 kg
n=7 Participants
|
7.97 kg
n=5 Participants
|
6.63 kg
n=4 Participants
|
39.79 kg
n=21 Participants
|
|
Body Mass Index
|
18.83 kg per square meter
n=5 Participants
|
19.12 kg per square meter
n=7 Participants
|
14.95 kg per square meter
n=5 Participants
|
14.73 kg per square meter
n=4 Participants
|
18.58 kg per square meter
n=21 Participants
|
|
Amount of morphine or hydromorphone taken prior to IMP
|
0.59 mg/kg
n=5 Participants
|
0.45 mg/kg
n=7 Participants
|
0.26 mg/kg
n=5 Participants
|
0.3 mg/kg
n=4 Participants
|
0.52 mg/kg
n=21 Participants
|
|
Type of opioid analgesia used
Hydromorphone
|
33 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Type of opioid analgesia used
Morphine
|
75 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 12 hoursPopulation: Full Analysis Set; subset of 160 participants from 2 to less than 18 years included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
The primary endpoint for the United States Food and Drug Administration (US FDA) (and secondary endpoint for the Pediatric Committee of the European Medicines Agency \[EU PDCO\]) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to \<18 years old) within 12 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
For the US FDA: The Total Amount of Supplemental Opioid Analgesic Medication Used Within the First 12 Hours After First Intake of Investigational Medicinal Product (IMP) [Tapentadol Oral Solution or Placebo]
|
0.08 mg/kg
Standard Error 0.01
|
0.13 mg/kg
Standard Error 0.02
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hoursPopulation: Full Analysis Set; subset of 160 participants from 2 to less than 18 years included in the analysis; if by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
The primary endpoint for the EU PDCO (and secondary endpoint for the US FDA) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to \<18 years old) within 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
For the EU PDCO: The Total Amount of Supplemental Opioid Analgesic Medication Used Within the First 24 Hours After First Intake of IMP [Tapentadol Oral Solution or Placebo]
|
0.14 mg/kg
Standard Error 0.03
|
0.24 mg/kg
Standard Error 0.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set; 175 participants aged from birth to \<18 years; participants with no documented SOAM use in the respective time period are excluded from calculations. When 0 participants are indicated in the Row Analyzed that means no data was collected.
The total amount of supplemental opioid analgesic medication (SOAM) received was assessed in 12-hour intervals from 24 hours to 96 hours after the first dose of IMP for participants who were administered SOAM. SOAM use was expressed in mg/kg of morphine i.v. equivalents.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
n=4 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP
72 h to 84 h
|
0.0 mg/kg
Interval 0.0 to 0.0
|
0.0 mg/kg
Interval 0.0 to 0.0
|
—
|
—
|
|
Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP
24 h to 36 h
|
0.08 mg/kg
Interval 0.0 to 0.4
|
0.14 mg/kg
Interval 0.0 to 0.7
|
0.020 mg/kg
Interval 0.02 to 0.02
|
0.003 mg/kg
Interval 0.003 to 0.003
|
|
Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP
36 h to 48 h
|
0.06 mg/kg
Interval 0.0 to 0.4
|
0.06 mg/kg
Interval 0.0 to 0.4
|
0.000 mg/kg
Interval 0.0 to 0.0
|
0.000 mg/kg
Interval 0.0 to 0.0
|
|
Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP
48 h to 60 h
|
0.05 mg/kg
Interval 0.0 to 0.4
|
0.06 mg/kg
Interval 0.0 to 0.4
|
—
|
—
|
|
Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP
60 h to 72 h
|
0.06 mg/kg
Interval 0.0 to 0.2
|
0.03 mg/kg
Interval 0.0 to 0.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set; subset of 160 participants aged from 2 years to less than 18 years included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
Palatability of IMP after the first dose was assessed in participants aged 2 years to less than 18 years using 5-point hedonic scales in combination with verbal rating. A question "How does the medication taste" was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range where 5 = really good, 4 = good, 3 = a bit good/a bit bad, 2 = bad, and 1 = really bad. Higher scores represent good palatability. Responses were summarized. Missing values were not imputed. Palatability data was not collected for participants \<2 years old.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Really bad
|
13 Participants
|
2 Participants
|
—
|
—
|
|
Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Bad
|
28 Participants
|
2 Participants
|
—
|
—
|
|
Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
A bit bad / a bit good
|
36 Participants
|
10 Participants
|
—
|
—
|
|
Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Good
|
24 Participants
|
24 Participants
|
—
|
—
|
|
Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Really good
|
6 Participants
|
11 Participants
|
—
|
—
|
|
Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Missing
|
1 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set: subset of 160 participants aged from 2 years to \<18 years included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
Acceptability of IMP in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question "Swallowing the medication is..." was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range, with 5 = really easy, 4 = easy, 3 = a bit easy/a bit difficult, 2 = difficult, and 1 = really difficult. Higher scores represent better acceptability. Responses were summarized. Missing values were not imputed. Acceptability data was not collected in participants \<2 years old.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Really difficult
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Difficult
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
A bit difficult/a bit easy
|
17 Participants
|
7 Participants
|
—
|
—
|
|
Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Easy
|
46 Participants
|
20 Participants
|
—
|
—
|
|
Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Really easy
|
35 Participants
|
19 Participants
|
—
|
—
|
|
Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale
Missing
|
2 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set: subset of 51 participants aged from birth to \<6 years included in the analysis; participants with missing data were excluded from calculations. No standard deviations were derived for less than 5 participants.
The FLACC scale was used for children from birth to less than 6 years, or in older children who were not able to report their pain using the other scales. This tool includes 5 categories of pain behaviors: facial expression (F), leg movement (L), activity (A), cry (C), and consolability (C). Each of the 5 categories is scored 0, 1 or 2. The total score between 0 and 10 is the sum of the 5 individual categories. Higher scores represent worse condition. The Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible, up to end of treatment (96 hours). Changes from baseline values were summarized descriptively for each time point.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=23 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=13 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
n=4 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
30-60 mins after 1st IMP
|
1.1 score on a scale
Interval -5.0 to 4.0
|
1.9 score on a scale
Interval 0.0 to 6.0
|
1.4 score on a scale
Interval -4.0 to 6.0
|
2.8 score on a scale
Interval 0.0 to 5.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
Before 2nd dose of IMP
|
1.4 score on a scale
Interval -2.0 to 7.0
|
1.3 score on a scale
Interval 0.0 to 6.0
|
0.7 score on a scale
Interval -5.0 to 6.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
Before 3rd dose of IMP
|
1.7 score on a scale
Interval -2.0 to 7.0
|
1.6 score on a scale
Interval -1.0 to 6.0
|
2.0 score on a scale
Interval 0.0 to 6.0
|
-1.3 score on a scale
Interval -6.0 to 2.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
Before 4th dose of IMP
|
1.4 score on a scale
Interval -2.0 to 5.0
|
1.3 score on a scale
Interval -1.0 to 6.0
|
1.3 score on a scale
Interval -5.0 to 5.0
|
0.0 score on a scale
Interval -5.0 to 3.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
Before 5th dose of IMP
|
1.8 score on a scale
Interval -1.0 to 5.0
|
1.9 score on a scale
Interval -1.0 to 6.0
|
1.4 score on a scale
Interval -2.0 to 6.0
|
2.0 score on a scale
Interval 0.0 to 4.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
Before 6th dose of IMP
|
1.6 score on a scale
Interval -2.0 to 5.0
|
2.3 score on a scale
Interval 0.0 to 6.0
|
2.0 score on a scale
Interval -1.0 to 6.0
|
2.5 score on a scale
Interval 0.0 to 5.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
Before 7th dose of IMP
|
1.6 score on a scale
Interval -2.0 to 6.0
|
2.1 score on a scale
Interval 0.0 to 6.0
|
1.9 score on a scale
Interval -1.0 to 6.0
|
2.0 score on a scale
Interval 0.0 to 3.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
Before 8th dose of IMP
|
1.2 score on a scale
Interval -1.0 to 4.0
|
2.2 score on a scale
Interval -3.0 to 6.0
|
3.8 score on a scale
Interval 1.0 to 6.0
|
-0.5 score on a scale
Interval -5.0 to 4.0
|
|
Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years
At End of Treatment
|
2.4 score on a scale
Interval -3.0 to 6.0
|
2.0 score on a scale
Interval -1.0 to 9.0
|
2.1 score on a scale
Interval -4.0 to 6.0
|
3.5 score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set: subset of 46 participants aged from 6 to less than 12 years included in the analysis; participants with missing data are not included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
For children aged 6 years (if possible) to less than 12 years, pain intensity was assessed by the use of the Faces Pain Scale-Revised (FPS-R). The FPS-R is a validated self-reported 6-point scale (0, 2, 4, 6, 8, 10) with 0 representing no pain and 10 representing very much pain. Facial representations were used to indicate how much the pain hurts. Higher scores represent worse condition. Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible. Changes from baseline pain values were summarized descriptively for each time point up to end of treatment (96 hours).
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=32 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=14 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
30-60 mins after 1st IMP
|
1.0 units on a scale
Standard Deviation 1.72
|
0.7 units on a scale
Standard Deviation 1.86
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
Before 2nd dose of IMP
|
1.0 units on a scale
Standard Deviation 2.5
|
0.5 units on a scale
Standard Deviation 2.84
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
Before 3rd dose of IMP
|
1.0 units on a scale
Standard Deviation 2.35
|
-0.2 units on a scale
Standard Deviation 2.17
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
Before 4th dose of IMP
|
1.3 units on a scale
Standard Deviation 2.33
|
-0.3 units on a scale
Standard Deviation 3.7
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
Before 5th dose of IMP
|
0.8 units on a scale
Standard Deviation 2.75
|
0 units on a scale
Standard Deviation 2.19
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
Before 6th dose of IMP
|
0.5 units on a scale
Standard Deviation 2.43
|
0.2 units on a scale
Standard Deviation 2.2
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
Before 7th dose of IMP
|
2.0 units on a scale
Standard Deviation 2.37
|
0.7 units on a scale
Standard Deviation 2.24
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
Before 8th dose of IMP
|
1.3 units on a scale
Standard Deviation 2.55
|
0.2 units on a scale
Standard Deviation 2.73
|
—
|
—
|
|
Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years
At End of Treatment
|
2.8 units on a scale
Standard Deviation 2.93
|
3.4 units on a scale
Standard Deviation 3.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set: subset of 78 participants aged from 12 to less than 18 years included in the analysis; participants with missing data are not included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
For children and adolescents aged 12 years to less than 18 years, pain intensity was assessed by the use of a Visual analog scale (VAS). The participant was asked to draw a single line to indicate the current level of pain intensity on a 100 mm long scale by marking a point on the line in response to: "My pain right now is". The mark was scored between "no pain" and "pain as bad as it could be". A value of 0 indicates "no pain". A value of 100 indicates "pain as bad as it could be". Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible. Changes from baseline values were summarized descriptively for each time point.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=53 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=25 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
30-60 mins after 1st IMP
|
8.0 units on a scale
Standard Deviation 18.67
|
6.4 units on a scale
Standard Deviation 19.58
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
Before 2nd dose of IMP
|
6.5 units on a scale
Standard Deviation 23.61
|
6.0 units on a scale
Standard Deviation 19.36
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
Before 3rd dose of IMP
|
13.1 units on a scale
Standard Deviation 25.09
|
5.9 units on a scale
Standard Deviation 22.11
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
Before 4th dose of IMP
|
8.8 units on a scale
Standard Deviation 29.01
|
5.1 units on a scale
Standard Deviation 21.7
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
Before 5th dose of IMP
|
13.0 units on a scale
Standard Deviation 22.92
|
-2.7 units on a scale
Standard Deviation 34.4
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
Before 6th dose of IMP
|
13.0 units on a scale
Standard Deviation 24.74
|
6.6 units on a scale
Standard Deviation 28.4
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
Before 7th dose of IMP
|
10.7 units on a scale
Standard Deviation 25.77
|
15.0 units on a scale
Standard Deviation 20.27
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
Before 8th dose of IMP
|
12.2 units on a scale
Standard Deviation 28.91
|
11.9 units on a scale
Standard Deviation 14.6
|
—
|
—
|
|
Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years
At End of Treatment
|
11.0 units on a scale
Standard Deviation 27.87
|
11.4 units on a scale
Standard Deviation 28.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4Population: Full Analysis Set; 175 participants from birth to less than 18 years are included. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
The CGIC was assessed at the End of Treatment Visit (Day 4). The investigator rated the participant's global improvement and satisfaction with the treatment on a 7-point scale with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher scores indicate worsening. Results were summarized descriptively.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
n=4 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Clinical Global Impression of Change (CGIC)
Minimally improved
|
18 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Global Impression of Change (CGIC)
No change
|
11 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGIC)
Very much improved
|
15 Participants
|
12 Participants
|
3 Participants
|
1 Participants
|
|
Clinical Global Impression of Change (CGIC)
Much improved
|
58 Participants
|
22 Participants
|
2 Participants
|
2 Participants
|
|
Clinical Global Impression of Change (CGIC)
Minimally worse
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGIC)
Much worse
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGIC)
Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Global Impression of Change (CGIC)
Missing
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 4Population: Full Analysis Set; 175 participants from birth to less than 18 years are included. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
The PGIC was assessed at the End of Treatment Visit (Day 4). Participants rated their impression of overall status on a 7-point scale with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher scores indicate worsening. If participants were not capable of completing the questionnaire, the parent/legal guardian could completed the questionnaire on behalf of the participant. Results were summarized descriptively.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
n=4 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
Very much improved
|
16 Participants
|
11 Participants
|
4 Participants
|
3 Participants
|
|
Patient Global Impression of Change (PGIC)
Much improved
|
53 Participants
|
23 Participants
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally improved
|
21 Participants
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
No change
|
13 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally worse
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Much worse
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Missing
|
3 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set; 175 participants from birth to less than 18 years are included, censored participants are not displayed. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
The time to first and time to second patient-controlled analgesia (PCA) or nurse-controlled analgesia (NCA) after the first dose of IMP were summarized descriptively using time-to-event methods and are displayed by relevant treatment groups. Participants who completed the End of Treatment Visit (scheduled for 96 hours after first IMP) before their first/second use of NCA/PCA or participants who terminated treatment before their first/second use of NCA/PCA were censored at the End of Treatment Visit. Time-to-event variables are reported using Kaplan-Meier analyses. Therefore, values might remain missing if the survival function does not reach a respective threshold. This is indicated by not applicable (NA).
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
n=4 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Time to Receive First and Second Patient- or Nurse-controlled Analgesia After the First Dose of IMP
Time to first NCA/PCA administration
|
183.0 minutes
Interval 90.0 to 446.0
|
131.5 minutes
Interval 74.0 to 216.0
|
960.0 minutes
Interval 80.0 to
Survival function did not reach threshold.
|
155.0 minutes
Interval 124.0 to
Survival function did not reach threshold.
|
|
Time to Receive First and Second Patient- or Nurse-controlled Analgesia After the First Dose of IMP
Time to second NCA/PCA administration
|
572.0 minutes
Interval 321.0 to 1993.0
|
388.0 minutes
Interval 194.0 to 820.0
|
NA minutes
Interval 210.0 to
Survival function did not reach threshold.
|
NA minutes
Interval 500.0 to
Survival function did not reach threshold.
|
SECONDARY outcome
Timeframe: Up to 72 hoursPopulation: Full Analysis Set; 160 participants from 2 to less than 18 years were included in the analysis. If by error a participant did not receive the allocated medication, he/she was evaluated as allocated following the intention-to-treat principle. No participant \<2 years was discontinued from treatment due to lack of efficacy; no analysis was performed.
The distributions of the time from the first dose of IMP to treatment discontinuation due to lack of efficacy were summarized descriptively using time-to-event methods. Participants who reached the maximum duration of treatment (72 hours) were censored at 72 hours after first IMP intake. Participants who discontinued during the Treatment Period for reasons other than lack of efficacy were censored at the time of the decision to discontinue treatment. Due to the low number of participants with events in the age group from 2 to \<18 years, the median time and the corresponding confidence interval could not be calculated. The number of participants who discontinued early due to lack of efficacy is presented instead.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
n=4 Participants
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Time From First Dose of IMP Until Treatment Discontinuation Due to Lack of Efficacy
Number of censored participants
|
104 Participants
|
48 Participants
|
11 Participants
|
4 Participants
|
|
Time From First Dose of IMP Until Treatment Discontinuation Due to Lack of Efficacy
Number of participants with event
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set; participants aged 2 to less than 18 years were included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
Palatability of IMP after the last dose in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question "How does the medication taste" was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range with 5 = really good, 4 = good, 3 = a bit good/a bit bad, 2 = bad, and 1 = really bad. Higher scores represent good palatability. Responses were summarized. Missing values were not imputed. Palatability data was not collected in participants \<2 years old.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Really bad
|
14 Participants
|
1 Participants
|
—
|
—
|
|
Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Bad
|
15 Participants
|
3 Participants
|
—
|
—
|
|
Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
A bit bad / a bit good
|
38 Participants
|
14 Participants
|
—
|
—
|
|
Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Good
|
28 Participants
|
16 Participants
|
—
|
—
|
|
Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Really good
|
5 Participants
|
12 Participants
|
—
|
—
|
|
Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Missing
|
8 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 96 hoursPopulation: Full Analysis Set; 160 participants aged 2 to less than 18 years were included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
Acceptability of IMP in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question "Swallowing the medication is..." was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range, with 5 = really easy, 4 = easy, 3 = a bit easy/a bit difficult, 2 = difficult, and 1 = really difficult. Higher scores represent better acceptability. Responses were summarized. Missing values were not imputed. Acceptability data was not collected in participants \<2 years old.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=108 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=52 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Really difficult
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Difficult
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
A bit difficult/a bit easy
|
9 Participants
|
6 Participants
|
—
|
—
|
|
Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Easy
|
43 Participants
|
18 Participants
|
—
|
—
|
|
Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Really easy
|
39 Participants
|
20 Participants
|
—
|
—
|
|
Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale
Missing
|
8 Participants
|
6 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hoursPopulation: Full Analysis Set: subset of 15 participants from birth to less than 2 years included in the analysis; participants with missing data were excluded from calculations. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
The mean amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set subset aged from birth to less than 2 years old was determined from 0 to 12 hours and from 0 to 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=11 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=4 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Mean Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years
0-12 hours
|
0.03 mg/kg
Interval 0.0 to 0.07
|
0.01 mg/kg
Interval 0.0 to 0.04
|
—
|
—
|
|
Mean Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years
0-24 hours
|
0.054 mg/kg
Interval 0.0 to 0.3
|
0.016 mg/kg
Interval 0.0 to 0.04
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hoursPopulation: Full Analysis Set: subset of 15 participants from birth to less than 2 years included in the analysis; participants with missing data were excluded from calculations. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.
The median amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set subset aged from birth to less than 2 years old was determined from 0 to 12 hours and from 0 to 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.
Outcome measures
| Measure |
Tapentadol (From 2 to <18 Years)
n=11 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From 2 to <18 Years)
n=4 Participants
This analysis subset included all participants aged 2 years to less than 18 years old who were allocated to placebo and received at least one dose of IMP.
|
Tapentadol (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to tapentadol and received at least one dose of IMP.
|
Placebo (From Birth to <2 Years)
This analysis subset included all participants aged from birth to less than 2 years old who were allocated to placebo and received at least one dose of IMP.
|
|---|---|---|---|---|
|
Median Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years
0-12 hours
|
0.00 mg/kg
Interval 0.0 to 0.07
|
0.01 mg/kg
Interval 0.0 to 0.04
|
—
|
—
|
|
Median Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years
0-24 hours
|
0.016 mg/kg
Interval 0.0 to 0.3
|
0.013 mg/kg
Interval 0.0 to 0.04
|
—
|
—
|
Adverse Events
Overall (From 2 to <18 Years)
Serious events: 2 serious events
Other events: 87 other events
Deaths: 0 deaths
Tapentadol (From 2 to <18 Years)
Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths
Placebo (From 2 to <18 Years)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Overall (From Birth to <2 Years)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Tapentadol (From Birth to <2 Years)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (From Birth to <2 Years)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall (From 2 to <18 Years)
n=160 participants at risk
All participants aged 2 years to below 18 years who received at least 1 dose of IMP.
|
Tapentadol (From 2 to <18 Years)
n=108 participants at risk
All participants aged 2 years to below 18 years who received at least 1 dose of tapentadol oral solution.
|
Placebo (From 2 to <18 Years)
n=52 participants at risk
All participants aged 2 years to below 18 years who received at least 1 dose of placebo oral solution.
|
Overall (From Birth to <2 Years)
n=15 participants at risk
All participants from birth to below 2 years who received at least 1 dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 participants at risk
All participants from birth to below 2 years who received at least 1 dose of tapentadol oral solution.
|
Placebo (From Birth to <2 Years)
n=4 participants at risk
All participants from birth to below 2 years who received at least 1 dose of placebo oral solution.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Nervous system disorders
Seizure
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
Other adverse events
| Measure |
Overall (From 2 to <18 Years)
n=160 participants at risk
All participants aged 2 years to below 18 years who received at least 1 dose of IMP.
|
Tapentadol (From 2 to <18 Years)
n=108 participants at risk
All participants aged 2 years to below 18 years who received at least 1 dose of tapentadol oral solution.
|
Placebo (From 2 to <18 Years)
n=52 participants at risk
All participants aged 2 years to below 18 years who received at least 1 dose of placebo oral solution.
|
Overall (From Birth to <2 Years)
n=15 participants at risk
All participants from birth to below 2 years who received at least 1 dose of IMP.
|
Tapentadol (From Birth to <2 Years)
n=11 participants at risk
All participants from birth to below 2 years who received at least 1 dose of tapentadol oral solution.
|
Placebo (From Birth to <2 Years)
n=4 participants at risk
All participants from birth to below 2 years who received at least 1 dose of placebo oral solution.
|
|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
General disorders
Face oedema
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
General disorders
Infusion site pruritus
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
General disorders
Pyrexia
|
6.9%
11/160 • Number of events 20 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
9.3%
10/108 • Number of events 19 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Psychiatric disorders
Agitation
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
9.1%
1/11 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Psychiatric disorders
Anxiety
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Psychiatric disorders
Initial insomnia
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Psychiatric disorders
Insomnia
|
1.2%
2/160 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
3.8%
2/52 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Psychiatric disorders
Withdrawal syndrome
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
1.2%
2/160 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.00%
0/160 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
25.0%
1/4 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Alanine aminotransferase increased
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Aspartate aminotransferase increased
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
9.1%
1/11 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Blood urea decreased
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Haematocrit decreased
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Hepatic enzyme increased
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Oxygen saturation decreased
|
2.5%
4/160 • Number of events 5 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
2.8%
3/108 • Number of events 4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
9.1%
1/11 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Po2 decreased
|
0.62%
1/160 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Red blood cell count decreased
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/160 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
25.0%
1/4 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Investigations
Haemoglobin decreased
|
1.2%
2/160 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Cardiac disorders
Anaemia
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Cardiac disorders
Haemorrhagic anaemia
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Cardiac disorders
Thrombocytopenia
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Cardiac disorders
Sinus Tachycardia
|
1.9%
3/160 • Number of events 3 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
2/108 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
3/160 • Number of events 3 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
2.8%
3/108 • Number of events 3 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Nervous system disorders
Dizziness
|
3.1%
5/160 • Number of events 8 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
3.7%
4/108 • Number of events 7 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Nervous system disorders
Headache
|
3.8%
6/160 • Number of events 7 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
4.6%
5/108 • Number of events 6 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Nervous system disorders
Sedation
|
1.2%
2/160 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
2/108 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Nervous system disorders
Somnolence
|
5.0%
8/160 • Number of events 8 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
5.6%
6/108 • Number of events 6 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
3.8%
2/52 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Eye disorders
Eye pain
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Constipation
|
10.6%
17/160 • Number of events 17 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
10.2%
11/108 • Number of events 11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
11.5%
6/52 • Number of events 6 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
9.1%
1/11 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Dysphagia
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Nausea
|
12.5%
20/160 • Number of events 27 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
14.8%
16/108 • Number of events 22 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
7.7%
4/52 • Number of events 5 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
31/160 • Number of events 44 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
23.1%
25/108 • Number of events 36 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
11.5%
6/52 • Number of events 8 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
13.3%
2/15 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
18.2%
2/11 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/160 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
9.1%
1/11 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/160 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
9.1%
1/11 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/160 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/108 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
6.7%
1/15 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
25.0%
1/4 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Renal and urinary disorders
Urinary retention
|
2.5%
4/160 • Number of events 4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
2.8%
3/108 • Number of events 3 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
7/160 • Number of events 7 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
3.7%
4/108 • Number of events 4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
5.8%
3/52 • Number of events 3 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.62%
1/160 • Number of events 3 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 3 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.2%
2/160 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.2%
2/160 • Number of events 2 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
1.9%
1/52 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.62%
1/160 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.93%
1/108 • Number of events 1 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/52 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/15 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/11 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
0.00%
0/4 • Any adverse event (AE) is reported that started at or after the first dose of IMP or started before the first dose of IMP and worsened in intensity after the first dose of IMP up to the end of the therapeutic reach of the last dose of IMP. The therapeutic reach is the time after IMP intake that a participant is still considered to be potentially affected by the study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours.
Adverse events are reported for all participants who received at least 1 dose of IMP (tapentadol or placebo) (Safety Set).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right to review any proposed presentation of the results of this trial before they are submitted for publication or public disclosure. Neither party (e.g., the sponsor, the coordinating investigator) has the right to prohibit publication or public disclosure unless it can be shown to affect possible patent rights.
- Publication restrictions are in place
Restriction type: OTHER