Trial Outcomes & Findings for A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents (NCT NCT01077362)
NCT ID: NCT01077362
Last Updated: 2014-02-27
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 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
312 participants
Primary outcome timeframe
Week 24
Results posted on
2014-02-27
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
103
|
105
|
|
Overall Study
COMPLETED
|
73
|
84
|
81
|
|
Overall Study
NOT COMPLETED
|
31
|
19
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
13
|
8
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
|
Overall Study
Adverse Event
|
12
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
5
|
|
Overall Study
Other
|
0
|
1
|
2
|
Baseline Characteristics
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
Baseline characteristics by cohort
| Measure |
Placebo
n=104 Participants
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=103 Participants
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=105 Participants
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 11.19 • n=5 Participants
|
48 years
STANDARD_DEVIATION 11.21 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 11.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
148 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 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=104 Participants
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=103 Participants
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=105 Participants
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=208 Participants
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
|
20.2 Percentage of participants
|
43.7 Percentage of participants
|
43.8 Percentage of participants
|
43.8 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.
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=104 Participants
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=103 Participants
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=105 Participants
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=208 Participants
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
|
|---|---|---|---|---|
|
Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
|
-0.03 Score on a scale
Standard Deviation 0.380
|
-0.21 Score on a scale
Standard Deviation 0.461
|
-0.22 Score on a scale
Standard Deviation 0.436
|
-0.21 Score on a scale
Standard Deviation 0.447
|
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. 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=80 Participants
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=80 Participants
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=81 Participants
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=161 Participants
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
|
|---|---|---|---|---|
|
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
|
5.0 Percentage of participants
|
51.3 Percentage of participants
|
55.6 Percentage of participants
|
53.4 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 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=104 Participants
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=103 Participants
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=105 Participants
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=208 Participants
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
|
6.7 Percentage of participants
|
17.5 Percentage of participants
|
22.9 Percentage of participants
|
20.2 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 scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the 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 the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be provided from an integrated analysis.
Outcome measures
| Measure |
Placebo
n=310 Participants
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=308 Participants
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=309 Participants
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=617 Participants
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
|
|---|---|---|---|---|
|
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
|
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 escaped, 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=104 Participants
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
|
Ustekinumab 45 mg
n=103 Participants
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
Ustekinumab 90 mg
n=105 Participants
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
|
All Ustekinumab Combined
n=208 Participants
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
|
2.9 Percentage of participants
|
6.8 Percentage of participants
|
8.6 Percentage of participants
|
7.7 Percentage of participants
|
Adverse Events
Placebo: Controlled Period
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Ustekinumab 45 mg: Controlled Period
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Ustekinumab 90 mg: Controlled Period
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo: Weeks 16-24
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo -> Ustekinumab 45 mg: Weeks 16-60
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Ustekinumab 45 mg: Weeks 16-60
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Ustekinumab 90 mg: Weeks 16-60
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: Controlled Period
n=104 participants at risk
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
|
Ustekinumab 45 mg: Controlled Period
n=103 participants at risk
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
|
Ustekinumab 90 mg: Controlled Period
n=104 participants at risk
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
|
Placebo: Weeks 16-24
n=60 participants at risk
Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
|
Placebo -> Ustekinumab 45 mg: Weeks 16-60
n=80 participants at risk
Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
|
Ustekinumab 45 mg: Weeks 16-60
n=100 participants at risk
Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
|
Ustekinumab 90 mg: Weeks 16-60
n=99 participants at risk
Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Septic Shock
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
2.0%
2/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.2%
1/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Infections and infestations
Gastrointestinal Candidiasis
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
General disorders
Pyrexia
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Psychiatric disorders
Depression
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.2%
1/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Nervous system disorders
Cerebrovascular Insufficiency
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Renal and urinary disorders
Renal Injury
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Vascular disorders
Hypertension
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.0%
1/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
Other adverse events
| Measure |
Placebo: Controlled Period
n=104 participants at risk
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
|
Ustekinumab 45 mg: Controlled Period
n=103 participants at risk
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
|
Ustekinumab 90 mg: Controlled Period
n=104 participants at risk
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
|
Placebo: Weeks 16-24
n=60 participants at risk
Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
|
Placebo -> Ustekinumab 45 mg: Weeks 16-60
n=80 participants at risk
Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
|
Ustekinumab 45 mg: Weeks 16-60
n=100 participants at risk
Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
|
Ustekinumab 90 mg: Weeks 16-60
n=99 participants at risk
Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
2.9%
3/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.97%
1/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
2.5%
2/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
2.0%
2/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
8.1%
8/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
5/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
7.8%
8/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
9.6%
10/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
5.0%
3/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
3.8%
3/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
6.0%
6/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
8.1%
8/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Infections and infestations
Sinusitis
|
2.9%
3/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.97%
1/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
2.9%
3/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.2%
1/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.00%
0/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
5.1%
5/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
4.8%
5/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
3.9%
4/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
0.96%
1/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.7%
1/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.2%
1/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
6.0%
6/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
2.0%
2/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
|
Nervous system disorders
Headache
|
3.8%
4/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
4.9%
5/103 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
4.8%
5/104 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
1.7%
1/60 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
5.0%
4/80 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
2.0%
2/100 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
3.0%
3/99 • Adverse event data were collected for the duration of the study (60 weeks).
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
|
Additional Information
Senior 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