Trial Outcomes & Findings for A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease (NCT NCT00784277)
NCT ID: NCT00784277
Last Updated: 2012-02-13
Results Overview
SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where "0" is no pain and "10" is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
597 participants
Primary outcome timeframe
Day 1 to Day 5
Results posted on
2012-02-13
Participant Flow
A total of 1000 participants were screened, 598 were randomized, 596 participants received medication in the first part of the double-blind treatment period (IR treatment phase). A total of 463 participants received medication in the second part of the double-blind treatment period (ER treatment phase).
Participant milestones
| Measure |
Placebo
IR Treatment : 1 capsule for 14 days
|
Tapentadol 50 mg
IR Treatment : 50mg for 14 days
|
Tapentadol 75 mg
IR Treatment : 75mg for 14 days
|
Oxycodone
IR Treatment : 10mg for 14 days
|
Placebo ER
ER Treatment : Tablets and capsules 2 x a day for 28 days
|
Tapentadol ER
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
|
Oxycodone CR
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
|
|---|---|---|---|---|---|---|---|
|
IR Treatment
STARTED
|
148
|
151
|
154
|
143
|
0
|
0
|
0
|
|
IR Treatment
COMPLETED
|
132
|
134
|
126
|
100
|
0
|
0
|
0
|
|
IR Treatment
NOT COMPLETED
|
16
|
17
|
28
|
43
|
0
|
0
|
0
|
|
ER Treatment
STARTED
|
0
|
0
|
0
|
0
|
122
|
250
|
91
|
|
ER Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
113
|
226
|
76
|
|
ER Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
9
|
24
|
15
|
Reasons for withdrawal
| Measure |
Placebo
IR Treatment : 1 capsule for 14 days
|
Tapentadol 50 mg
IR Treatment : 50mg for 14 days
|
Tapentadol 75 mg
IR Treatment : 75mg for 14 days
|
Oxycodone
IR Treatment : 10mg for 14 days
|
Placebo ER
ER Treatment : Tablets and capsules 2 x a day for 28 days
|
Tapentadol ER
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
|
Oxycodone CR
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
|
|---|---|---|---|---|---|---|---|
|
IR Treatment
Adverse Event
|
4
|
8
|
19
|
35
|
0
|
0
|
0
|
|
IR Treatment
Lack of Efficacy
|
4
|
4
|
1
|
0
|
0
|
0
|
0
|
|
IR Treatment
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
IR Treatment
Withdrawal by Subject
|
5
|
1
|
4
|
6
|
0
|
0
|
0
|
|
IR Treatment
Resolution Of Pain
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
IR Treatment
Other
|
2
|
3
|
3
|
2
|
0
|
0
|
0
|
|
ER Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
7
|
7
|
|
ER Treatment
Lack of Efficacy
|
0
|
0
|
0
|
0
|
3
|
4
|
0
|
|
ER Treatment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
ER Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
5
|
3
|
|
ER Treatment
Study Medication Non-Compliant
|
0
|
0
|
0
|
0
|
2
|
3
|
3
|
|
ER Treatment
Other
|
0
|
0
|
0
|
0
|
1
|
3
|
2
|
Baseline Characteristics
A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=148 Participants
IR Treatment : 1 capsule for 14 days
|
Tapentadol 50 mg
n=151 Participants
IR Treatment : 50mg capsule for 14 days
|
Tapentadol 75 mg
n=154 Participants
IR Treatment : 75mg capsule for 14 days
|
Oxycodone
n=143 Participants
IR Treatment : 10mg capsule for 14 days
|
Total
n=596 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
110 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
446 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
|
Age Continuous
|
58.8 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
58 years
STANDARD_DEVIATION 9.47 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 7.94 • n=4 Participants
|
58.7 years
STANDARD_DEVIATION 8.70 • n=21 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
349 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Region Enroll
Canada
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Region Enroll
USA
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
457 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 5Population: Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).
SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where "0" is no pain and "10" is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).
Outcome measures
| Measure |
Placebo
n=148 Participants
IR Treatment : 1 capsule for 14 days
|
Tapentadol 50 mg
n=150 Participants
IR Treatment : 50mg capsule for 14 days
|
Tapentadol 75 mg
n=154 Participants
IR Treatment : 75mg capsule for 14 days
|
Oxycodone
n=143 Participants
IR Treatment : 10mg capsule for 14 days
|
|---|---|---|---|---|
|
5-Day Sum of Pain Intensity Difference (SPID5)
|
98.6 Units on a scale
Standard Deviation 134.73
|
153.1 Units on a scale
Standard Deviation 184.07
|
161.8 Units on a scale
Standard Deviation 187.31
|
218.4 Units on a scale
Standard Deviation 208.64
|
PRIMARY outcome
Timeframe: Week 1 to Week 2Population: Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).
The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.
Outcome measures
| Measure |
Placebo
n=148 Participants
IR Treatment : 1 capsule for 14 days
|
Tapentadol 50 mg
n=150 Participants
IR Treatment : 50mg capsule for 14 days
|
Tapentadol 75 mg
n=154 Participants
IR Treatment : 75mg capsule for 14 days
|
Oxycodone
n=143 Participants
IR Treatment : 10mg capsule for 14 days
|
|---|---|---|---|---|
|
Spontaneous Bowel Movements Per Week (SBMs/Week)
|
9.9 number of stools/week
Standard Deviation 5.16
|
9.0 number of stools/week
Standard Deviation 4.04
|
8.6 number of stools/week
Standard Deviation 4.65
|
6.7 number of stools/week
Standard Deviation 5.44
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Tapentadol 50 mg
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
Tapentadol 75 mg
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
Oxycodone
Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths
Placebo ER
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Tapentadol ER
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Oxycodone CR
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=148 participants at risk
IR Treatment : 1 capsule for 14 days
|
Tapentadol 50 mg
n=151 participants at risk
IR Treatment : 50mg for 14 days
|
Tapentadol 75 mg
n=154 participants at risk
IR Treatment : 75mg for 14 days
|
Oxycodone
n=143 participants at risk
IR Treatment : 10mg for 14 days
|
Placebo ER
n=122 participants at risk
ER Treatment : Tablets and capsules 2 x a day for 28 days
|
Tapentadol ER
n=250 participants at risk
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
|
Oxycodone CR
n=91 participants at risk
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Kidney infection
|
0.00%
0/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.66%
1/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.68%
1/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.70%
1/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.40%
1/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.40%
1/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
Other adverse events
| Measure |
Placebo
n=148 participants at risk
IR Treatment : 1 capsule for 14 days
|
Tapentadol 50 mg
n=151 participants at risk
IR Treatment : 50mg for 14 days
|
Tapentadol 75 mg
n=154 participants at risk
IR Treatment : 75mg for 14 days
|
Oxycodone
n=143 participants at risk
IR Treatment : 10mg for 14 days
|
Placebo ER
n=122 participants at risk
ER Treatment : Tablets and capsules 2 x a day for 28 days
|
Tapentadol ER
n=250 participants at risk
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
|
Oxycodone CR
n=91 participants at risk
ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.4%
11/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
17.2%
26/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
20.1%
31/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
39.9%
57/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.1%
5/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
9.2%
23/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
13.2%
12/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
14.9%
22/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
13.9%
21/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
18.2%
28/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
29.4%
42/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
8.2%
10/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
14.8%
37/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
19.8%
18/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
1/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.6%
7/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
8.4%
13/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
23.8%
34/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.1%
5/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
5.2%
13/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
6.6%
6/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
5/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
2.6%
4/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.5%
7/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
3.5%
5/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.1%
5/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
5.2%
13/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.4%
4/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.68%
1/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
2.6%
4/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
5.8%
9/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.2%
6/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.82%
1/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
1.2%
3/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
1.1%
1/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Nervous system disorders
Somnolence
|
3.4%
5/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
13.2%
20/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
9.1%
14/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
11.9%
17/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
1.6%
2/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
3.2%
8/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
2.2%
2/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Nervous system disorders
Dizziness
|
4.1%
6/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
11.3%
17/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
22.7%
35/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
17.5%
25/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
3.3%
4/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
2.0%
5/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
3.3%
3/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Nervous system disorders
Headache
|
8.1%
12/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.0%
6/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.5%
7/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
10.5%
15/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
5.7%
7/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
3.2%
8/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
4.4%
4/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.68%
1/148
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
1.3%
2/151
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
2.6%
4/154
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
9.1%
13/143
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
0.00%
0/122
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
1.2%
3/250
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
2.2%
2/91
Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. participants with Non-Serious Adverse Events.
|
Additional Information
Senior Director, Clinical Leader
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 609-730-4537
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60