Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis (NCT NCT01009086)
NCT ID: NCT01009086
Last Updated: 2015-03-03
Results Overview
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters \[cm\]) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
615 participants
Primary outcome timeframe
Week 24
Results posted on
2015-03-03
Participant Flow
Participant milestones
| Measure |
Group 1: PLACEBO
Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
|
Group 2: USTEKINUMAB 45 MG
Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
|
Group 3: USTEKINUMAB 90 MG
Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
|
|---|---|---|---|
|
Overall Study
STARTED
|
206
|
205
|
204
|
|
Overall Study
COMPLETED
|
162
|
158
|
170
|
|
Overall Study
NOT COMPLETED
|
44
|
47
|
34
|
Reasons for withdrawal
| Measure |
Group 1: PLACEBO
Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
|
Group 2: USTEKINUMAB 45 MG
Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
|
Group 3: USTEKINUMAB 90 MG
Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
16
|
15
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
3
|
|
Overall Study
Adverse Event
|
12
|
11
|
8
|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
13
|
|
Overall Study
Other
|
3
|
5
|
1
|
Baseline Characteristics
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Group 1: PLACEBO
n=206 Participants
Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
|
Group 2: USTEKINUMAB 45 MG
n=205 Participants
Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
|
Group 3: USTEKINUMAB 90 MG
n=204 Participants
Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
|
Total
n=615 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 12.64 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 11.75 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 12.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
285 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
330 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters \[cm\]) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=205 Participants
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=204 Participants
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=409 Participants
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
|
22.8 Percentage of participants
|
42.4 Percentage of participants
|
49.5 Percentage of participants
|
46.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 24Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=205 Participants
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=204 Participants
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=409 Participants
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
|
|---|---|---|---|---|
|
Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
|
-0.10 Score on a scale
Standard Deviation 0.390
|
-0.31 Score on a scale
Standard Deviation 0.521
|
-0.40 Score on a scale
Standard Deviation 0.514
|
-0.36 Score on a scale
Standard Deviation 0.518
|
SECONDARY outcome
Timeframe: Week 24Population: All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with \>=3% baseline BSA psoriatic involvement were included in this analysis.
The PASI is a physician-administered assessment tool 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 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.
Outcome measures
| Measure |
Placebo
n=146 Participants
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=145 Participants
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=149 Participants
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=294 Participants
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
|
|---|---|---|---|---|
|
Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
|
11.0 Percentage of participants
|
57.2 Percentage of participants
|
62.4 Percentage of participants
|
59.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=205 Participants
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=204 Participants
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=409 Participants
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
|
8.7 Percentage of participants
|
24.9 Percentage of participants
|
27.9 Percentage of participants
|
26.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=205 Participants
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=204 Participants
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=409 Participants
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
|
2.4 Percentage of participants
|
12.2 Percentage of participants
|
14.2 Percentage of participants
|
13.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 24Population: Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.
The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.
Outcome measures
| Measure |
Placebo
n=310 Participants
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=308 Participants
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=309 Participants
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=617 Participants
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
|
|---|---|---|---|---|
|
Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002
|
0.97 Score on a scale
Standard Deviation 3.852
|
0.40 Score on a scale
Standard Deviation 2.110
|
0.39 Score on a scale
Standard Deviation 2.403
|
0.40 Score on a scale
Standard Deviation 2.260
|
Adverse Events
Placebo (CP)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Ustekinumab 45 mg (CP)
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Ustekinumab 90 mg (CP)
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo (After CP)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo -> Ustekinumab 45 mg (After CP)
Serious events: 14 serious events
Other events: 50 other events
Deaths: 0 deaths
Ustekinumab 45 mg (After CP)
Serious events: 20 serious events
Other events: 42 other events
Deaths: 0 deaths
Ustekinumab 90 mg (After CP)
Serious events: 13 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (CP)
n=205 participants at risk
Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
|
Ustekinumab 45 mg (CP)
n=205 participants at risk
Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
|
Ustekinumab 90 mg (CP)
n=204 participants at risk
Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
|
Placebo (After CP)
n=140 participants at risk
After Controlled period (Week 16-24) - participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
|
Placebo -> Ustekinumab 45 mg (After CP)
n=189 participants at risk
After Controlled period (Week 16-108) - participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
|
Ustekinumab 45 mg (After CP)
n=203 participants at risk
After Controlled period (Week 16-108) - participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
|
Ustekinumab 90 mg (After CP)
n=199 participants at risk
After Controlled period (Week 16-108) - participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenic Purpura
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Angina Pectoris
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.99%
2/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
General disorders
Chest Pain
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Hepatobiliary disorders
Chronic Hepatitis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Parotitis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Pharyngolaryngeal Abscess
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Proteus Infection
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Finger Deformity
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Psychiatric disorders
Depression
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.71%
1/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.71%
1/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Renal and urinary disorders
Tubulointerstitial Nephritis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Reproductive system and breast disorders
Cervical Polyp
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic Psoriasis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.71%
1/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.50%
1/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Vascular disorders
Hypertension
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.53%
1/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
Other adverse events
| Measure |
Placebo (CP)
n=205 participants at risk
Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
|
Ustekinumab 45 mg (CP)
n=205 participants at risk
Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
|
Ustekinumab 90 mg (CP)
n=204 participants at risk
Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
|
Placebo (After CP)
n=140 participants at risk
After Controlled period (Week 16-24) - participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
|
Placebo -> Ustekinumab 45 mg (After CP)
n=189 participants at risk
After Controlled period (Week 16-108) - participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
|
Ustekinumab 45 mg (After CP)
n=203 participants at risk
After Controlled period (Week 16-108) - participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
|
Ustekinumab 90 mg (After CP)
n=199 participants at risk
After Controlled period (Week 16-108) - participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.9%
8/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
3.9%
8/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
5.4%
11/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
1.4%
2/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
7.9%
15/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
8.9%
18/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
10.1%
20/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.9%
10/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
2.4%
5/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
4.4%
9/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
1.4%
2/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
8.5%
16/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
6.9%
14/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
6.0%
12/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Infections and infestations
Urinary Tract Infection
|
0.98%
2/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.49%
1/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.98%
2/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.71%
1/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
3.2%
6/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
2.0%
4/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
5.5%
11/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
3.4%
7/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
2.0%
4/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
0.00%
0/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
5.3%
10/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
3.0%
6/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
4.5%
9/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
|
Vascular disorders
Hypertension
|
2.0%
4/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
1.5%
3/205 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
2.9%
6/204 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
1.4%
2/140 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
3.7%
7/189 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
4.4%
9/203 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
5.5%
11/199 • Baseline up to Week 108
Safety population included all participants who received the investigational drug and had safety data.
|
Additional Information
Director, Clinical Research
Janssen Research & Development, LLC
Phone: 1-800-526-7736
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