Trial Outcomes & Findings for A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy (NCT NCT01516008)

Results Overview

Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

353 participants

Primary outcome timeframe

48 hours

Results posted on

2014-04-28

Participant Flow

The study was conducted from 11 January 2012 to 2 February 2013. Participants were recruited at 17 study centers in Korea.

353 participants were randomly allocated to the 3 treatment arms. 352 participants received at least 1 dose of the study drug and were included in the intent-to-treat (ITT) analysis set.

Participant milestones

Participant milestones
Measure	Placebo Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Study STARTED	114	121	117
Overall Study COMPLETED	69	105	99
Overall Study NOT COMPLETED	45	16	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Study Adverse Event	0	2	7
Overall Study Lack of Efficacy	44	14	10
Overall Study Protocol Violation	1	0	0
Overall Study Reason not specified	0	0	1

Baseline Characteristics

A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Total n=352 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 11.62 • n=5 Participants	51.8 years STANDARD_DEVIATION 11.9 • n=7 Participants	50.7 years STANDARD_DEVIATION 13.45 • n=5 Participants	51.3 years STANDARD_DEVIATION 12.33 • n=4 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	114 Participants n=7 Participants	108 Participants n=5 Participants	331 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Region of Enrollment Korea, Republic Of	114 participants n=5 Participants	121 participants n=7 Participants	117 participants n=5 Participants	352 participants n=4 Participants
Age Customized <65 years	103 participants n=5 Participants	105 participants n=7 Participants	99 participants n=5 Participants	307 participants n=4 Participants
Age Customized >=65 years	11 participants n=5 Participants	16 participants n=7 Participants	18 participants n=5 Participants	45 participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.

Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Sum of Pain Intensity Differences (SPID) Over 48 Hours	65.3 Scores on a scale Standard Deviation 121.04	131.7 Scores on a scale Standard Deviation 107.19	154.5 Scores on a scale Standard Deviation 124.03

SECONDARY outcome

Timeframe: Up to 48 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.

Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Time to First Rescue Medication Use	NA Hours Interval 6.7 to The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (38.6 percent) used rescue medication.	NA Hours The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (14.0 percent) used rescue medication.	NA Hours The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (9.4 percent) used rescue medication.

SECONDARY outcome

Timeframe: Baseline (Day 1) and 12, 24, 48, and 72 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.

Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours 12 hours	0.0 Percentage Reduction Interval 0.0 to 30.0	28.6 Percentage Reduction Interval 0.0 to 50.0	28.6 Percentage Reduction Interval 12.5 to 60.0
Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours 24 hours	20.0 Percentage Reduction Interval 0.0 to 50.0	44.4 Percentage Reduction Interval 22.2 to 60.0	50.0 Percentage Reduction Interval 25.0 to 71.4
Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours 48 hours	41.4 Percentage Reduction Interval 0.0 to 71.4	66.7 Percentage Reduction Interval 42.9 to 80.0	70.0 Percentage Reduction Interval 40.0 to 83.3
Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours 72 hours	60.0 Percentage Reduction Interval 0.0 to 85.7	77.8 Percentage Reduction Interval 57.1 to 90.0	80.0 Percentage Reduction Interval 50.0 to 90.0

SECONDARY outcome

Timeframe: 12, 24, 48, and 72 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.

Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 12 hours	27.2 Percentage of participants	47.9 Percentage of participants	49.6 Percentage of participants
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 24 hours	39.5 Percentage of participants	68.6 Percentage of participants	70.9 Percentage of participants
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 48 hours	53.5 Percentage of participants	79.3 Percentage of participants	76.9 Percentage of participants
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 72 hours	57.9 Percentage of participants	81.8 Percentage of participants	80.3 Percentage of participants

SECONDARY outcome

Timeframe: 12, 24, 48, and 72 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.

Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 72 hours	56.1 Percentage of participants	79.3 Percentage of participants	76.9 Percentage of participants
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 48 hours	48.2 Percentage of participants	71.1 Percentage of participants	70.1 Percentage of participants
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 12 hours	11.4 Percentage of participants	28.9 Percentage of participants	32.5 Percentage of participants
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours 24 hours	31.6 Percentage of participants	46.3 Percentage of participants	54.7 Percentage of participants

SECONDARY outcome

Timeframe: 12, 24, and 72 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.

Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours 12 hours	5.7 Scores on a scale Standard Deviation 23.59	20.4 Scores on a scale Standard Deviation 22.29	24.6 Scores on a scale Standard Deviation 28.18
Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours 72 hours	127.9 Scores on a scale Standard Deviation 198.61	234.5 Scores on a scale Standard Deviation 170.84	264.1 Scores on a scale Standard Deviation 192.70
Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours 24 hours	17.7 Scores on a scale Standard Deviation 51.88	48.1 Scores on a scale Standard Deviation 47.92	60.1 Scores on a scale Standard Deviation 58.56

SECONDARY outcome

Timeframe: 12, 24, 48, and 72 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values

Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours 12 hours	7.8 Scores on a scale Standard Deviation 7.21	15.0 Scores on a scale Standard Deviation 8.94	15.1 Scores on a scale Standard Deviation 9.99
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours 24 hours	19.4 Scores on a scale Standard Deviation 16.91	34.5 Scores on a scale Standard Deviation 19.04	35.1 Scores on a scale Standard Deviation 19.50
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours 48 hours	53.8 Scores on a scale Standard Deviation 44.60	88.4 Scores on a scale Standard Deviation 40.24	87.6 Scores on a scale Standard Deviation 41.34
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours 72 hours	94.7 Scores on a scale Standard Deviation 76.12	151.3 Scores on a scale Standard Deviation 64.14	148.5 Scores on a scale Standard Deviation 65.29

SECONDARY outcome

Timeframe: 12, 24, 48, and 72 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.

Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours 12 hours	13.6 Scores on a scale Standard Deviation 29.13	35.4 Scores on a scale Standard Deviation 28.74	39.7 Scores on a scale Standard Deviation 36.18
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours 24 hours	37.1 Scores on a scale Standard Deviation 65.27	82.6 Scores on a scale Standard Deviation 61.99	95.2 Scores on a scale Standard Deviation 74.14
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours 48 hours	119.1 Scores on a scale Standard Deviation 159.28	220.2 Scores on a scale Standard Deviation 137.54	242.1 Scores on a scale Standard Deviation 157.04
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours 72 hours	222.6 Scores on a scale Standard Deviation 265.92	385.7 Scores on a scale Standard Deviation 220.15	412.6 Scores on a scale Standard Deviation 244.92

SECONDARY outcome

Timeframe: Baseline (Day 1) and 72 hours

Population: Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.

The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 Participants Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 Participants Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Patient Global Impression of Change (PGI-C) Score at 72 Hours Much Improved	23.7 Percentage of participants	36.4 Percentage of participants	37.6 Percentage of participants
Patient Global Impression of Change (PGI-C) Score at 72 Hours Much Worse	6.1 Percentage of participants	0.8 Percentage of participants	1.7 Percentage of participants
Patient Global Impression of Change (PGI-C) Score at 72 Hours Very Much Worse	0.9 Percentage of participants	1.7 Percentage of participants	0.9 Percentage of participants
Patient Global Impression of Change (PGI-C) Score at 72 Hours Very Much Improved	28.9 Percentage of participants	44.6 Percentage of participants	46.2 Percentage of participants
Patient Global Impression of Change (PGI-C) Score at 72 Hours Minimally Improved	11.4 Percentage of participants	8.3 Percentage of participants	6.0 Percentage of participants
Patient Global Impression of Change (PGI-C) Score at 72 Hours No Change	21.1 Percentage of participants	5.0 Percentage of participants	6.0 Percentage of participants
Patient Global Impression of Change (PGI-C) Score at 72 Hours Minimally Worse	7.9 Percentage of participants	3.3 Percentage of participants	1.7 Percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Tapentadol IR 50 mg

Serious events: 2 serious events

Other events: 58 other events

Deaths: 0 deaths

Tapentadol IR 75 mg

Serious events: 0 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=114 participants at risk Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 participants at risk Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 participants at risk Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Injury, poisoning and procedural complications Procedural site reaction	0.00% 0/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	0.83% 1/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	0.00% 0/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.
Nervous system disorders Essential tremor	0.00% 0/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	0.83% 1/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	0.00% 0/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.

Other adverse events

Other adverse events
Measure	Placebo n=114 participants at risk Each participant received matching placebo once every 4 to 6 hours for 3 days	Tapentadol IR 50 mg n=121 participants at risk Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days	Tapentadol IR 75 mg n=117 participants at risk Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Gastrointestinal disorders Constipation	0.88% 1/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	5.8% 7/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	6.8% 8/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.
Gastrointestinal disorders Nausea	7.0% 8/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	36.4% 44/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	44.4% 52/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.
Gastrointestinal disorders Vomiting	3.5% 4/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	11.6% 14/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	22.2% 26/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.
General disorders Pyrexia	9.6% 11/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	4.1% 5/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	6.8% 8/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.
Injury, poisoning and procedural complications Procedural dizziness	2.6% 3/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	11.6% 14/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	18.8% 22/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.
Nervous system disorders Dizziness postural	0.00% 0/114 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	5.0% 6/121 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.	5.1% 6/117 • Up to Day 30 For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.

Additional Information

Clinical Leader

Janssen Research & Development, L.L.C.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60