Trial Outcomes & Findings for A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain (NCT NCT01008618)
NCT ID: NCT01008618
Last Updated: 2013-12-25
Results Overview
Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
218 participants
Primary outcome timeframe
Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)
Results posted on
2013-12-25
Participant Flow
Participant milestones
| Measure |
Fentanyl (Titration Period)
One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
|
Fentanyl (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|---|
|
Period 1 (Titration Period)
STARTED
|
218
|
0
|
0
|
|
Period 1 (Titration Period)
COMPLETED
|
150
|
0
|
0
|
|
Period 1 (Titration Period)
NOT COMPLETED
|
68
|
0
|
0
|
|
Period 2 (Double-Blind Period)
STARTED
|
0
|
73
|
77
|
|
Period 2 (Double-Blind Period)
COMPLETED
|
0
|
37
|
39
|
|
Period 2 (Double-Blind Period)
NOT COMPLETED
|
0
|
36
|
38
|
Reasons for withdrawal
| Measure |
Fentanyl (Titration Period)
One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
|
Fentanyl (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|---|
|
Period 1 (Titration Period)
Physician Decision
|
2
|
0
|
0
|
|
Period 1 (Titration Period)
Adverse Event
|
33
|
0
|
0
|
|
Period 1 (Titration Period)
Withdrawal by Subject
|
11
|
0
|
0
|
|
Period 1 (Titration Period)
Not satisfied criteria to enter Period 2
|
20
|
0
|
0
|
|
Period 1 (Titration Period)
Aggravated symptom
|
2
|
0
|
0
|
|
Period 2 (Double-Blind Period)
Adverse Event
|
0
|
11
|
2
|
|
Period 2 (Double-Blind Period)
Withdrawal by Subject
|
0
|
3
|
2
|
|
Period 2 (Double-Blind Period)
Physician Decision
|
0
|
1
|
0
|
|
Period 2 (Double-Blind Period)
Insufficient analgesic efficacy
|
0
|
0
|
3
|
|
Period 2 (Double-Blind Period)
More than 3 times a day rescue treatment
|
0
|
0
|
1
|
|
Period 2 (Double-Blind Period)
More than 15mm increase in Mean VAS
|
0
|
21
|
29
|
|
Period 2 (Double-Blind Period)
Not appropriate for this study
|
0
|
0
|
1
|
Baseline Characteristics
A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain
Baseline characteristics by cohort
| Measure |
Fentanyl (Titration Period)
n=218 Participants
One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
|
|---|---|
|
Age, Continuous
|
66.8 Years
STANDARD_DEVIATION 13.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)Population: Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.
Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=73 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
|
NA Days
The data was not estimable due to the high number of participants censored for this outcome measure.
|
NA Days
Interval 21.0 to
The data was not estimable due to the high number of participants censored for this outcome measure.
|
SECONDARY outcome
Timeframe: Day 12-14 (Screening period) and Day 27-29 (Titration period)Population: Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=218 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Pain Visual Analog Scale (VAS) Score - Titration Period
Last 3 days in Screening period (n=218)
|
74.1 mm
Standard Deviation 12.37
|
—
|
|
Pain Visual Analog Scale (VAS) Score - Titration Period
Last 3 days in titration period (n=216)
|
39.71 mm
Standard Deviation 21.41
|
—
|
SECONDARY outcome
Timeframe: Day 27-29 (Titration period) and Day 83-85 (double-blind period)Population: The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=73 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Pain Visual Analog Scale (VAS) Score - Double-Blind Period
Last 3 days in double-blind period (n=72, 77)
|
28.9 mm
Standard Deviation 18.99
|
36.5 mm
Standard Deviation 22.29
|
|
Pain Visual Analog Scale (VAS) Score - Double-Blind Period
Last 3 days in titration period (n=73, 77)
|
28.9 mm
Standard Deviation 12.71
|
29.6 mm
Standard Deviation 12.05
|
SECONDARY outcome
Timeframe: Day 1 and 29 or final evaluation (Titration period)Population: The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=218 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
Day 1, Category 1 (n=218)
|
77 Participants
|
—
|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
Day 1, Category 2 (n=218)
|
11 Participants
|
—
|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
Day 29/Final evaluation, Category 1 (n=218)
|
183 Participants
|
—
|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
Day 29/ Final evaluation, Category 2 (n=218)
|
124 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 85 or final evaluation (double-blind period)Population: The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=73 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
Day 1, Category 1 (n=73, 77)
|
71 Participants
|
76 Participants
|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
Day 1, Category 2 (n=73, 77)
|
57 Participants
|
63 Participants
|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
Day 85/Final evaluation, Category 1 (n=73, 77)
|
63 Participants
|
56 Participants
|
|
Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
Day 85/Final evaluation, Category 2 (n=73, 77)
|
42 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day 1 and 29 or final evaluation (Titration period)Population: The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=218 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Number of Doses of Rescue Treatment Per Day - Titration Period
Day 1 (n=218)
|
0.0 Treatments per day
Standard Deviation 0.19 • Interval 0.0 to 3.0
|
—
|
|
Number of Doses of Rescue Treatment Per Day - Titration Period
Day 29/Final evaluation (n=218)
|
0.2 Treatments per day
Standard Deviation 0.45
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 85 or final evaluation (double-blind period)Population: The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=73 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Number of Doses of Rescue Treatment Per Day - Double-Blind Period
Day 1 (n=73, 77)
|
0.0 Treatments per day
Standard Deviation 0.16 • Interval 0.0 to 2.0
|
0.0 Treatments per day
Standard Deviation 0.11 • Interval 0.0 to 2.0
|
|
Number of Doses of Rescue Treatment Per Day - Double-Blind Period
Day 85/Final evaluation (n=72, 77)
|
0.2 Treatments per day
Standard Deviation 0.49
|
0.2 Treatments per day
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Day 1 and 29 or final evaluation (Titration period)Population: The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=218 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
Day 29/Final evaluation (n=217)
|
4.0 Units on a scale
Standard Deviation 2.19
|
—
|
|
Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
Day 1 (n=218)
|
5.9 Units on a scale
Standard Deviation 1.66
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 85 or final evaluation (double-blind period)Population: The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=73 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
Day 1 (n=73, 77)
|
3.2 Units on a scale
Standard Deviation 1.65
|
3.2 Units on a scale
Standard Deviation 1.66
|
|
Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
Day 85/Final evaluation (n=73, 77)
|
3.2 Units on a scale
Standard Deviation 1.83
|
3.9 Units on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Day 1 and 29 or final evaluation (Titration period)Population: The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=218 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period
Day 1, Physical Component Score (n=218)
|
17.1 Units on a scale
Standard Deviation 14.91
|
—
|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period
Day 1, Mental Component Score (n=218)
|
48.2 Units on a scale
Standard Deviation 9.92
|
—
|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period
Day 29/Final, Physical Component Score (n=217)
|
23.3 Units on a scale
Standard Deviation 15.56
|
—
|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period
Day 29/Final, Mental Component Score (n=217)
|
48.5 Units on a scale
Standard Deviation 9.57
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 85 or final evaluation (double-blind period)Population: The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=73 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:
Day 1, Physical Component Score (n=73, 77)
|
25.8 Units on a scale
Standard Deviation 14.71
|
22.8 Units on a scale
Standard Deviation 14.30
|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:
Day 1, Mental Component Score (n=73, 77)
|
50.1 Units on a scale
Standard Deviation 8.29
|
50.8 Units on a scale
Standard Deviation 9.13
|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:
Day 85/Final, Physical Component Score (n=73, 77)
|
24.3 Units on a scale
Standard Deviation 16.11
|
22.5 Units on a scale
Standard Deviation 14.64
|
|
Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:
Day 85/Final, Mental Component Score (n=73, 77)
|
49.9 Units on a scale
Standard Deviation 9.82
|
51.0 Units on a scale
Standard Deviation 10.41
|
SECONDARY outcome
Timeframe: Day 29 or final evaluation (Titration period)Population: The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.
Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=218 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
Effective
|
185 Participants
|
—
|
|
Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
Ineffective
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 85 or final evaluation (double-blind period)Population: The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.
Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.
Outcome measures
| Measure |
Fentanyl (Double-blind Period)
n=73 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 Participants
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|
|
Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
Day 1, Effective (n= 73, 77)
|
73 Participants
|
77 Participants
|
|
Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
Day 1, Ineffective (n= 73, 77)
|
0 Participants
|
0 Participants
|
|
Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
Day 85/Final evaluation, Effective (n= 73, 77)
|
64 Participants
|
51 Participants
|
|
Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
Day 85/Final evaluation, Ineffective (n= 73, 77)
|
9 Participants
|
26 Participants
|
Adverse Events
Fentanyl (Titration Period)
Serious events: 12 serious events
Other events: 177 other events
Deaths: 0 deaths
Fentanyl (Double-blind Period)
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo (Double-blind Period)
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl (Titration Period)
n=218 participants at risk
One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
|
Fentanyl (Double-blind Period)
n=73 participants at risk
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 participants at risk
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.4%
3/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Ear and labyrinth disorders
Positional vertigo
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Dizziness
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Delirium
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Hallucinations
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Somnolence
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Vascular disorders
Chronic heart failure
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Gastric discomfort
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Aspiration pneumonia
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Lassitude
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Death
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
Other adverse events
| Measure |
Fentanyl (Titration Period)
n=218 participants at risk
One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
|
Fentanyl (Double-blind Period)
n=73 participants at risk
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
Placebo (Double-blind Period)
n=77 participants at risk
Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.8%
6/218 • From Screening period up to the Follow-up period
|
13.7%
10/73 • From Screening period up to the Follow-up period
|
10.4%
8/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Chronic sinusitis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Impetigo
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Tinea pedis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Urinary tract infection
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
4.1%
3/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
3/218 • From Screening period up to the Follow-up period
|
2.7%
2/73 • From Screening period up to the Follow-up period
|
6.5%
5/77 • From Screening period up to the Follow-up period
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Insomnia
|
2.3%
5/218 • From Screening period up to the Follow-up period
|
9.6%
7/73 • From Screening period up to the Follow-up period
|
3.9%
3/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Hallucination
|
1.4%
3/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Delirium
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Hallucination, visual
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Abnormal behaviour
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Somnolence
|
27.1%
59/218 • From Screening period up to the Follow-up period
|
4.1%
3/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Dizziness
|
12.4%
27/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Headache
|
6.9%
15/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Dysgeusia
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Dysarthria
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Head discomfort
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Hypoaesthesia
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Myelopathy
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Tremor
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Eye disorders
Diplopia
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Eye disorders
Lacrimation increased
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Eye disorders
Vision blurred
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Ear and labyrinth disorders
Vertigo
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Cardiac disorders
Palpitations
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Vascular disorders
Flushing
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Vascular disorders
Hypertension
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Vascular disorders
Raynaud's phenomenon
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
4/218 • From Screening period up to the Follow-up period
|
4.1%
3/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Nausea
|
41.7%
91/218 • From Screening period up to the Follow-up period
|
6.8%
5/73 • From Screening period up to the Follow-up period
|
7.8%
6/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Constipation
|
30.3%
66/218 • From Screening period up to the Follow-up period
|
8.2%
6/73 • From Screening period up to the Follow-up period
|
3.9%
3/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
29/218 • From Screening period up to the Follow-up period
|
4.1%
3/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
11/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
9/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Stomatitis
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
2.7%
2/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Dyspepsia
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Eructation
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Faeces hard
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Gastritis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
2.7%
2/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Periodontitis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.8%
4/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Hepatobiliary disorders
Liver disorder
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
6/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.8%
6/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
5/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
3/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
4.1%
3/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Renal and urinary disorders
Dysuria
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Renal and urinary disorders
Pollakiuria
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Renal and urinary disorders
Haematuria
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site pruritus
|
5.5%
12/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Malaise
|
4.1%
9/218 • From Screening period up to the Follow-up period
|
4.1%
3/73 • From Screening period up to the Follow-up period
|
3.9%
3/77 • From Screening period up to the Follow-up period
|
|
General disorders
Thirst
|
1.8%
4/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
3.9%
3/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site dermatitis
|
1.4%
3/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Feeling abnormal
|
1.4%
3/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site erythema
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Drug withdrawal syndrome
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
5.5%
4/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Hypothermia
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Oedema
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Pyrexia
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
2.7%
2/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site rash
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Chest pain
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Oedema peripheral
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
2.7%
2/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Temperature regulation disorder
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Sensation of foreign body
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site discomfort
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Blood pressure increased
|
2.3%
5/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Investigations
Aspartate aminotransferase increased
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Investigations
White blood cell count increased
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Alanine aminotransferase increased
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Blood creatinine increased
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Investigations
Blood pressure decreased
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Blood urea increased
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Investigations
C-reactive protein increased
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Glucose urine present
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Laboratory test abnormal
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Liver function test abnormal
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Blood alkaline phosphatase increased
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Injury, poisoning and procedural complications
Fall
|
0.92%
2/218 • From Screening period up to the Follow-up period
|
2.7%
2/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Injury, poisoning and procedural complications
Contusion
|
0.46%
1/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Cystitis
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Bronchitis
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Infections and infestations
Anal abscess
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Eye disorders
Cataract
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
2.7%
2/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Renal and urinary disorders
Benign prostatic hyperplasia
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site reaction
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Chest discomfort
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Facial pain
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Fatigue
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Injection site extravasation
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Irritability
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
General disorders
Pain
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
General disorders
Application site eczema
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Investigations
Weight decreased
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
2.6%
2/77 • From Screening period up to the Follow-up period
|
|
Investigations
Blood potassium decreased
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Eosinophil count increased
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Blood urine present
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Monocyte count increased
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Investigations
Protein urine present
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
0.00%
0/73 • From Screening period up to the Follow-up period
|
1.3%
1/77 • From Screening period up to the Follow-up period
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/218 • From Screening period up to the Follow-up period
|
1.4%
1/73 • From Screening period up to the Follow-up period
|
0.00%
0/77 • From Screening period up to the Follow-up period
|
Additional Information
Director, Clinical Research
Janssen Research & Development, L.L.C. USA
Phone: 1 609 730-3387
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER