Trial Outcomes & Findings for A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis (NCT NCT01550744)
NCT ID: NCT01550744
Last Updated: 2017-02-09
Results Overview
Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
478 participants
Primary outcome timeframe
Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])
Results posted on
2017-02-09
Participant Flow
During this study, two subjects were transferred between sites and counted twice. Hence, a total of 478 subjects were enrolled in this trial.
Participant milestones
| Measure |
Ustekinumab 45 mg/Ustekinumab 90 mg
Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (\<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (\>) 100 kg at Week 0.
|
Group 1: Approved q12w Maintenance Regimen
Randomized double-blind period (Week 28-124) - Participants who weighed \<= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
Group 2: Subject-tailored Fixed-interval Maintenance Regimen
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed \<= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
|---|---|---|---|
|
Open-Label
STARTED
|
478
|
0
|
0
|
|
Open-Label
COMPLETED
|
378
|
0
|
0
|
|
Open-Label
NOT COMPLETED
|
100
|
0
|
0
|
|
Double-Blind
STARTED
|
0
|
76
|
302
|
|
Double-Blind
COMPLETED
|
0
|
59
|
235
|
|
Double-Blind
NOT COMPLETED
|
0
|
17
|
67
|
Reasons for withdrawal
| Measure |
Ustekinumab 45 mg/Ustekinumab 90 mg
Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (\<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (\>) 100 kg at Week 0.
|
Group 1: Approved q12w Maintenance Regimen
Randomized double-blind period (Week 28-124) - Participants who weighed \<= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
Group 2: Subject-tailored Fixed-interval Maintenance Regimen
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed \<= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
|---|---|---|---|
|
Open-Label
Lost to Follow-up
|
7
|
0
|
0
|
|
Open-Label
Withdrawal by Subject
|
13
|
0
|
0
|
|
Open-Label
Adverse Event
|
11
|
0
|
0
|
|
Open-Label
Lack of Efficacy
|
4
|
0
|
0
|
|
Open-Label
Protocol Violation
|
4
|
0
|
0
|
|
Open-Label
Not all 3 study drug injections received
|
2
|
0
|
0
|
|
Open-Label
Static PGA-cleared/minimal not achieved
|
58
|
0
|
0
|
|
Open-Label
Other
|
1
|
0
|
0
|
|
Double-Blind
Lost to Follow-up
|
0
|
6
|
12
|
|
Double-Blind
Withdrawal by Subject
|
0
|
2
|
15
|
|
Double-Blind
Adverse Event
|
0
|
4
|
15
|
|
Double-Blind
Death
|
0
|
1
|
0
|
|
Double-Blind
Lack of Efficacy
|
0
|
2
|
8
|
|
Double-Blind
Protocol Violation
|
0
|
0
|
4
|
|
Double-Blind
Pregnancy
|
0
|
0
|
3
|
|
Double-Blind
Other
|
0
|
2
|
10
|
Baseline Characteristics
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Ustekinumab 45 mg/Ustekinumab 90 mg
n=478 Participants
Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (\<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (\>) 100 kg at Week 0.
|
|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 14.19 • n=5 Participants
|
|
Gender
Female
|
177 Participants
n=5 Participants
|
|
Gender
Male
|
301 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
478 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])Population: The "subjects randomized at Week 28 data set" was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.
Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.
Outcome measures
| Measure |
Group 1: Ustekinumab q12w Maintenance Regimen (MR)
n=76 Participants
Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed \> 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
|
Group 2: Ustekinumab Subject-tailored Fixed-interval MR
n=302 Participants
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed \> 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
|
|---|---|---|
|
The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)
|
4.5 number of visits
95% Confidence Interval 3.07 • Interval 3.81 to 5.21
|
4.1 number of visits
95% Confidence Interval 2.93 • Interval 3.72 to 4.39
|
SECONDARY outcome
Timeframe: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112Population: The Analysis population was "subjects randomized at Week 28 data set". 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.
Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.
Outcome measures
| Measure |
Group 1: Ustekinumab q12w Maintenance Regimen (MR)
n=76 Participants
Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed \> 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
|
Group 2: Ustekinumab Subject-tailored Fixed-interval MR
n=302 Participants
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed \> 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
|
|---|---|---|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 28 (n=76, 302)
|
100 percentage of participants
|
100 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 32 (n=75, 297)
|
78.7 percentage of participants
|
71.0 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 36 (n=74, 288)
|
75.7 percentage of participants
|
59.0 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 40 (n=73, 280)
|
67.1 percentage of participants
|
56.4 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 44 (n=71, 278)
|
74.6 percentage of participants
|
68.3 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 48 (n=69, 269)
|
69.6 percentage of participants
|
69.9 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 52 (n=69, 274)
|
71.0 percentage of participants
|
66.4 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 56 (n=68, 271)
|
73.5 percentage of participants
|
61.3 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 60 (n=68, 268)
|
70.6 percentage of participants
|
67.9 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 64 (n=69, 268)
|
59.4 percentage of participants
|
65.7 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 68 (n=69, 264)
|
75.4 percentage of participants
|
57.2 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 72 (n=66, 262)
|
74.2 percentage of participants
|
63.7 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 76 (n=66, 264)
|
60.6 percentage of participants
|
58.7 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 80 (n=65, 258)
|
67.7 percentage of participants
|
53.5 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 84 (n=63, 258)
|
68.3 percentage of participants
|
55.0 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 88 (n=64, 257)
|
57.8 percentage of participants
|
60.7 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 92 (n=64, 254)
|
65.6 percentage of participants
|
57.9 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 96 (n=62, 254)
|
58.1 percentage of participants
|
56.3 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 100 (n=64, 250)
|
59.4 percentage of participants
|
50.8 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 104 (n=65, 250)
|
64.6 percentage of participants
|
56.4 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 108 (n=63, 244)
|
60.3 percentage of participants
|
58.6 percentage of participants
|
|
The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time
Week 112 (n=58, 242)
|
53.4 percentage of participants
|
55.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])Population: The "subjects randomized at Week 28 data set" was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (\>=) 75 percent (%) improvement in PASI score from baseline.
Outcome measures
| Measure |
Group 1: Ustekinumab q12w Maintenance Regimen (MR)
n=76 Participants
Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed \> 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
|
Group 2: Ustekinumab Subject-tailored Fixed-interval MR
n=302 Participants
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed \> 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
|
|---|---|---|
|
The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response
|
5.8 number of visits
Standard Deviation 2.31
|
5.4 number of visits
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112Population: The Analysis population was "subjects randomized at Week 28 data set". 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (\>=) 75 percent (%) improvement in PASI score from baseline.
Outcome measures
| Measure |
Group 1: Ustekinumab q12w Maintenance Regimen (MR)
n=76 Participants
Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed \> 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
|
Group 2: Ustekinumab Subject-tailored Fixed-interval MR
n=302 Participants
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed less than or equal to (\<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed \> 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
|
|---|---|---|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 88 (n=64, 257)
|
81.3 percentage of participants
|
78.2 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 28 (n=76, 302)
|
96.1 percentage of participants
|
95.7 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 32 (n=75, 297)
|
92.0 percentage of participants
|
81.1 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 36 (n=74, 288)
|
93.2 percentage of participants
|
78.8 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 40 (n=73, 280)
|
86.3 percentage of participants
|
77.5 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 44 (n=71, 278)
|
90.1 percentage of participants
|
83.5 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 48 (n=69, 269)
|
89.9 percentage of participants
|
82.9 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 52 (n=69, 274)
|
82.6 percentage of participants
|
84.7 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 56 (n=68, 271)
|
85.3 percentage of participants
|
83.8 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 60 (n=68, 268)
|
91.2 percentage of participants
|
82.8 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 64 (n=69, 268)
|
79.7 percentage of participants
|
83.2 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 68 (n=69, 264)
|
85.5 percentage of participants
|
79.9 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 72 (n=66, 262)
|
83.3 percentage of participants
|
83.6 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 76 (n=66, 264)
|
77.3 percentage of participants
|
79.9 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 80 (n=65, 258)
|
81.5 percentage of participants
|
76.4 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 84 (n=63, 258)
|
84.1 percentage of participants
|
74.8 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 92 (n=64, 254)
|
84.4 percentage of participants
|
77.2 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 96 (n=62, 254)
|
82.3 percentage of participants
|
79.1 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 100 (n=64, 250)
|
76.6 percentage of participants
|
75.6 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 104 (n=65, 250)
|
81.5 percentage of participants
|
79.2 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 108 (n=63, 244)
|
82.5 percentage of participants
|
79.9 percentage of participants
|
|
The Percentage of Participants With a PASI 75 Response Over Time
Week 112 (n=58, 242)
|
74.1 percentage of participants
|
77.7 percentage of participants
|
Adverse Events
Ustekinumab 45 mg/Ustekinumab 90 mg
Serious events: 14 serious events
Other events: 73 other events
Deaths: 0 deaths
Group 1: Approved q12w Maintenance Regimen
Serious events: 7 serious events
Other events: 39 other events
Deaths: 0 deaths
Group 2: Subject-tailored Fixed-interval Maintenance Regimen
Serious events: 21 serious events
Other events: 131 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ustekinumab 45 mg/Ustekinumab 90 mg
n=478 participants at risk
Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (\<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (\>) 100 kg at Week 0.
|
Group 1: Approved q12w Maintenance Regimen
n=76 participants at risk
Randomized double-blind period (Week 28-124) - Participants who weighed \<= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
Group 2: Subject-tailored Fixed-interval Maintenance Regimen
n=302 participants at risk
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed \<= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Cardiac disorders
Cardiomyopathy
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Cardiac disorders
Myocardial Infarction
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
General disorders
Death
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Abscess Limb
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Appendicitis Perforated
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Cellulitis
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Cystitis
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.66%
2/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Myeloid Leukaemia
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Nervous system disorders
Carotid Artery Occlusion
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Nervous system disorders
Drug Withdrawal Convulsions
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Psychiatric disorders
Homicidal Ideation
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Surgical and medical procedures
Hernia Diaphragmatic Repair
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Surgical and medical procedures
Spinal Laminectomy
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.33%
1/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Vascular disorders
Haematoma
|
0.21%
1/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
Other adverse events
| Measure |
Ustekinumab 45 mg/Ustekinumab 90 mg
n=478 participants at risk
Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (\<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (\>) 100 kg at Week 0.
|
Group 1: Approved q12w Maintenance Regimen
n=76 participants at risk
Randomized double-blind period (Week 28-124) - Participants who weighed \<= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
Group 2: Subject-tailored Fixed-interval Maintenance Regimen
n=302 participants at risk
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to \[\>=2\]). Participants who weighed \<= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed \> 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.0%
24/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
9.2%
7/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
15.6%
47/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Sinusitis
|
1.3%
6/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
3.9%
3/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
5.6%
17/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.2%
25/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
27.6%
21/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
19.5%
59/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
7/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
5.3%
4/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
3.0%
9/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Investigations
Transaminases Increased
|
0.00%
0/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
5.3%
4/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
0.00%
0/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
5/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
7.9%
6/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
4.6%
14/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
8/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
1.3%
1/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
5.3%
16/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
|
Vascular disorders
Hypertension
|
0.84%
4/478 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
7.9%
6/76 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
5.3%
16/302 • Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER