Trial Outcomes & Findings for An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis (NCT NCT02325219)
NCT ID: NCT02325219
Last Updated: 2020-05-22
Results Overview
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
Week 16
Results posted on
2020-05-22
Participant Flow
Participant milestones
| Measure |
Placebo (Controlled Period [CP])
Participants stratified by the type of psoriasis (with or without PsA) received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|---|
|
Controlled Period (Week 0 - 16)
STARTED
|
64
|
65
|
63
|
0
|
0
|
|
Controlled Period (Week 0 - 16)
COMPLETED
|
52
|
63
|
62
|
0
|
0
|
|
Controlled Period (Week 0 - 16)
NOT COMPLETED
|
12
|
2
|
1
|
0
|
0
|
|
After Controlled Period (Week 16 - 52)
STARTED
|
0
|
63
|
62
|
26
|
26
|
|
After Controlled Period (Week 16 - 52)
COMPLETED
|
0
|
60
|
62
|
26
|
25
|
|
After Controlled Period (Week 16 - 52)
NOT COMPLETED
|
0
|
3
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Controlled Period [CP])
Participants stratified by the type of psoriasis (with or without PsA) received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 50 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|---|
|
Controlled Period (Week 0 - 16)
Adverse Event
|
6
|
1
|
0
|
0
|
0
|
|
Controlled Period (Week 0 - 16)
Withdrawal by Subject
|
6
|
1
|
0
|
0
|
0
|
|
Controlled Period (Week 0 - 16)
Other
|
0
|
0
|
1
|
0
|
0
|
|
After Controlled Period (Week 16 - 52)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
After Controlled Period (Week 16 - 52)
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
|
After Controlled Period (Week 16 - 52)
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 10.56 • n=93 Participants
|
50.1 years
STANDARD_DEVIATION 12.66 • n=4 Participants
|
47.8 years
STANDARD_DEVIATION 11.07 • n=27 Participants
|
48.8 years
STANDARD_DEVIATION 11.46 • n=483 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
145 Participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
64 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
192 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
|
7.8 percentage of participants
|
92.3 percentage of participants
|
88.9 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
|
0 percentage of participants
|
70.8 percentage of participants
|
69.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved PASI 75 Response at Week 16
|
6.3 percentage of participants
|
89.2 percentage of participants
|
84.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
|
-0.8 units on a scale
Standard Deviation 5.40
|
-8.3 units on a scale
Standard Deviation 5.87
|
-8.5 units on a scale
Standard Deviation 6.95
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 2: IGA 0 responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 2: IGA 0/1 responders
|
0 percentage of participants
|
3.1 percentage of participants
|
9.5 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 2: IGA 0/1/2 responders
|
10.9 percentage of participants
|
47.7 percentage of participants
|
46.0 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 4: IGA 0 responders
|
0 percentage of participants
|
1.5 percentage of participants
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 4: IGA 0/1 responders
|
1.6 percentage of participants
|
27.7 percentage of participants
|
25.4 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 4: IGA 0/1/2 responders
|
20.3 percentage of participants
|
81.5 percentage of participants
|
77.8 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 8: IGA 0 responders
|
0 percentage of participants
|
16.9 percentage of participants
|
20.6 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 8: IGA 0/1 responders
|
1.6 percentage of participants
|
76.9 percentage of participants
|
65.1 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 8: IGA 0/1/2 responders
|
20.3 percentage of participants
|
93.8 percentage of participants
|
93.7 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 12: IGA 0 responders
|
0 percentage of participants
|
33.8 percentage of participants
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 12: IGA 0/1 responders
|
4.7 percentage of participants
|
89.2 percentage of participants
|
84.1 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 12: IGA 0/1/2 responders
|
25.0 percentage of participants
|
95.4 percentage of participants
|
96.8 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 16: IGA 0 responders
|
0 percentage of participants
|
44.6 percentage of participants
|
44.4 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 16: IGA 0/1 responders
|
7.8 percentage of participants
|
92.3 percentage of participants
|
88.9 percentage of participants
|
—
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16
Week 16: IGA 0/1/2 responders
|
28.1 percentage of participants
|
96.9 percentage of participants
|
96.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 52: IGA 0/1/2 responders
|
98.5 percentage of participants
|
98.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 20: IGA 0 responders
|
46.2 percentage of participants
|
57.1 percentage of participants
|
3.8 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 20: IGA 0/1 responders
|
89.2 percentage of participants
|
92.1 percentage of participants
|
57.7 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 20: IGA 0/1/2 responders
|
96.9 percentage of participants
|
96.8 percentage of participants
|
84.6 percentage of participants
|
88.5 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 24: IGA 0 responders
|
53.8 percentage of participants
|
57.1 percentage of participants
|
15.4 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 24: IGA 0/1 responders
|
90.8 percentage of participants
|
88.9 percentage of participants
|
88.5 percentage of participants
|
80.8 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 24: IGA 0/1/2 responders
|
98.5 percentage of participants
|
96.8 percentage of participants
|
96.2 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 28: IGA 0 responders
|
53.8 percentage of participants
|
49.2 percentage of participants
|
50.0 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 28: IGA 0/1 responders
|
90.8 percentage of participants
|
88.9 percentage of participants
|
100.0 percentage of participants
|
88.5 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 28: IGA 0/1/2 responders
|
98.5 percentage of participants
|
95.2 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 32: IGA 0 responders
|
47.7 percentage of participants
|
55.6 percentage of participants
|
53.8 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 32: IGA 0/1 responders
|
89.2 percentage of participants
|
90.5 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 32: IGA 0/1/2 responders
|
98.5 percentage of participants
|
96.8 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 36: IGA 0 responders
|
44.6 percentage of participants
|
55.6 percentage of participants
|
61.5 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 36: IGA 0/1 responders
|
89.2 percentage of participants
|
90.5 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 36: IGA 0/1/2 responders
|
98.5 percentage of participants
|
96.8 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 40: IGA 0 responders
|
49.2 percentage of participants
|
55.6 percentage of participants
|
65.4 percentage of participants
|
57.7 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 40: IGA 0/1 responders
|
87.7 percentage of participants
|
92.1 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 40: IGA 0/1/2 responders
|
96.9 percentage of participants
|
98.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 44: IGA 0 responders
|
55.4 percentage of participants
|
52.4 percentage of participants
|
61.5 percentage of participants
|
57.7 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 44: IGA 0/1 responders
|
86.2 percentage of participants
|
88.9 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 44: IGA 0/1/2 responders
|
98.5 percentage of participants
|
96.8 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 48: IGA 0 responders
|
50.8 percentage of participants
|
60.3 percentage of participants
|
73.1 percentage of participants
|
57.7 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 48: IGA 0/1 responders
|
86.2 percentage of participants
|
87.3 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 48: IGA 0/1/2 responders
|
98.5 percentage of participants
|
96.8 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 52: IGA 0 responders
|
53.8 percentage of participants
|
58.7 percentage of participants
|
53.8 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 52: IGA 0/1 responders
|
87.7 percentage of participants
|
90.5 percentage of participants
|
100.0 percentage of participants
|
88.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 2: PASI 50 responders
|
0 percentage of participants
|
4.6 percentage of participants
|
17.5 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 2: PASI 75 responders
|
0 percentage of participants
|
0 percentage of participants
|
1.6 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 2: PASI 90 responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 2: PASI 100 responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 4: PASI 50 responders
|
1.6 percentage of participants
|
49.2 percentage of participants
|
49.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 4: PASI 75 responders
|
0 percentage of participants
|
15.4 percentage of participants
|
17.5 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 4: PASI 90 responders
|
0 percentage of participants
|
4.6 percentage of participants
|
4.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 4: PASI 100 responders
|
0 percentage of participants
|
1.5 percentage of participants
|
1.6 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 8: PASI 50 responders
|
9.4 percentage of participants
|
87.7 percentage of participants
|
79.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 8: PASI 75 responders
|
0 percentage of participants
|
55.4 percentage of participants
|
50.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 8: PASI 90 responders
|
0 percentage of participants
|
30.8 percentage of participants
|
30.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 8: PASI 100 responders
|
0 percentage of participants
|
7.7 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 12: PASI 50 responders
|
7.8 percentage of participants
|
90.8 percentage of participants
|
92.1 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 12: PASI 75 responders
|
3.1 percentage of participants
|
78.5 percentage of participants
|
79.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 12: PASI 90 responders
|
0 percentage of participants
|
47.7 percentage of participants
|
38.1 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 12: PASI 100 responders
|
0 percentage of participants
|
16.9 percentage of participants
|
22.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 16: PASI 50 responders
|
14.1 percentage of participants
|
93.8 percentage of participants
|
95.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 16: PASI 75 responders
|
6.3 percentage of participants
|
89.2 percentage of participants
|
84.1 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 16: PASI 90 responders
|
0 percentage of participants
|
70.8 percentage of participants
|
69.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16
Week 16: PASI 100 responders
|
0 percentage of participants
|
32.3 percentage of participants
|
27.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 20: PASI 50 responders
|
95.4 percentage of participants
|
96.8 percentage of participants
|
57.7 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 20: PASI 75 responders
|
90.8 percentage of participants
|
88.9 percentage of participants
|
46.2 percentage of participants
|
30.8 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 20: PASI 90 responders
|
70.8 percentage of participants
|
71.4 percentage of participants
|
19.2 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 20: PASI 100 responders
|
33.8 percentage of participants
|
34.9 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 24: PASI 50 responders
|
98.5 percentage of participants
|
98.4 percentage of participants
|
92.3 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 24: PASI 75 responders
|
90.8 percentage of participants
|
90.5 percentage of participants
|
80.8 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 24: PASI 90 responders
|
78.5 percentage of participants
|
76.2 percentage of participants
|
42.3 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 24: PASI 100 responders
|
41.5 percentage of participants
|
44.4 percentage of participants
|
11.5 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 28: PASI 50 responders
|
98.5 percentage of participants
|
98.4 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 28: PASI 75 responders
|
92.3 percentage of participants
|
90.5 percentage of participants
|
88.5 percentage of participants
|
80.8 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 28: PASI 90 responders
|
75.4 percentage of participants
|
77.8 percentage of participants
|
73.1 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 28: PASI 100 responders
|
44.6 percentage of participants
|
38.1 percentage of participants
|
30.8 percentage of participants
|
34.6 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 32: PASI 50 responders
|
98.5 percentage of participants
|
98.4 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 32: PASI 75 responders
|
92.3 percentage of participants
|
90.5 percentage of participants
|
92.3 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 32: PASI 90 responders
|
76.9 percentage of participants
|
76.2 percentage of participants
|
76.9 percentage of participants
|
69.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 32: PASI 100 responders
|
41.5 percentage of participants
|
44.4 percentage of participants
|
34.6 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 36: PASI 50 responders
|
98.5 percentage of participants
|
95.2 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 36: PASI 75 responders
|
92.3 percentage of participants
|
90.5 percentage of participants
|
96.2 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 36: PASI 90 responders
|
78.5 percentage of participants
|
76.2 percentage of participants
|
84.6 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 36: PASI 100 responders
|
36.9 percentage of participants
|
42.9 percentage of participants
|
30.8 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 40: PASI 50 responders
|
98.5 percentage of participants
|
98.4 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 40: PASI 75 responders
|
90.8 percentage of participants
|
90.5 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 40: PASI 90 responders
|
78.5 percentage of participants
|
77.8 percentage of participants
|
96.2 percentage of participants
|
73.1 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 40: PASI 100 responders
|
33.8 percentage of participants
|
44.4 percentage of participants
|
38.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 44: PASI 50 responders
|
98.5 percentage of participants
|
95.2 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 44: PASI 75 responders
|
90.8 percentage of participants
|
88.9 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 44: PASI 90 responders
|
80.0 percentage of participants
|
74.6 percentage of participants
|
88.5 percentage of participants
|
73.1 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 44: PASI 100 responders
|
38.5 percentage of participants
|
44.4 percentage of participants
|
42.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 48: PASI 50 responders
|
98.5 percentage of participants
|
96.8 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 48: PASI 75 responders
|
90.8 percentage of participants
|
93.7 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 48: PASI 90 responders
|
75.4 percentage of participants
|
77.8 percentage of participants
|
100.0 percentage of participants
|
76.9 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 48: PASI 100 responders
|
36.9 percentage of participants
|
49.2 percentage of participants
|
46.2 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 52: PASI 50 responders
|
98.5 percentage of participants
|
98.4 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 52: PASI 75 responders
|
92.3 percentage of participants
|
90.5 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 52: PASI 90 responders
|
75.4 percentage of participants
|
77.8 percentage of participants
|
92.3 percentage of participants
|
73.1 percentage of participants
|
|
Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
Week 52: PASI 100 responders
|
38.5 percentage of participants
|
47.6 percentage of participants
|
38.5 percentage of participants
|
42.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 2
|
0.4 percent change
Standard Deviation 18.55
|
20.1 percent change
Standard Deviation 20.85
|
23.6 percent change
Standard Deviation 23.76
|
—
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 4
|
0.0 percent change
Standard Deviation 27.74
|
45.3 percent change
Standard Deviation 26.72
|
44.9 percent change
Standard Deviation 30.80
|
—
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 8
|
1.5 percent change
Standard Deviation 32.73
|
74.5 percent change
Standard Deviation 22.39
|
70.3 percent change
Standard Deviation 25.42
|
—
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 12
|
0.5 percent change
Standard Deviation 38.28
|
83.7 percent change
Standard Deviation 20.00
|
82.9 percent change
Standard Deviation 18.56
|
—
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 16
|
0.2 percent change
Standard Deviation 45.53
|
88.9 percent change
Standard Deviation 17.34
|
88.7 percent change
Standard Deviation 17.77
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 20
|
89.4 percent change
Standard Deviation 18.21
|
90.6 percent change
Standard Deviation 16.45
|
58.7 percent change
Standard Deviation 33.67
|
51.9 percent change
Standard Deviation 39.06
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 24
|
91.6 percent change
Standard Deviation 14.59
|
92.1 percent change
Standard Deviation 15.51
|
80.7 percent change
Standard Deviation 24.87
|
78.8 percent change
Standard Deviation 22.44
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 28
|
91.9 percent change
Standard Deviation 14.05
|
91.4 percent change
Standard Deviation 16.24
|
91.6 percent change
Standard Deviation 10.81
|
85.6 percent change
Standard Deviation 20.60
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 32
|
92.5 percent change
Standard Deviation 12.38
|
92.0 percent change
Standard Deviation 15.78
|
93.1 percent change
Standard Deviation 8.59
|
89.1 percent change
Standard Deviation 19.66
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 36
|
92.2 percent change
Standard Deviation 13.42
|
90.5 percent change
Standard Deviation 19.40
|
94.7 percent change
Standard Deviation 6.76
|
91.5 percent change
Standard Deviation 13.84
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 40
|
92.3 percent change
Standard Deviation 13.86
|
92.1 percent change
Standard Deviation 15.86
|
96.4 percent change
Standard Deviation 3.87
|
92.3 percent change
Standard Deviation 14.08
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 44
|
91.8 percent change
Standard Deviation 17.30
|
91.1 percent change
Standard Deviation 17.26
|
96.6 percent change
Standard Deviation 4.39
|
92.2 percent change
Standard Deviation 14.28
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 48
|
91.5 percent change
Standard Deviation 17.28
|
92.1 percent change
Standard Deviation 16.14
|
97.9 percent change
Standard Deviation 2.73
|
91.8 percent change
Standard Deviation 14.21
|
|
Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52
Week 52
|
91.6 percent change
Standard Deviation 17.12
|
92.5 percent change
Standard Deviation 15.39
|
96.7 percent change
Standard Deviation 4.45
|
91.4 percent change
Standard Deviation 14.02
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 2
|
0.0 units on a scale
Standard Deviation 4.44
|
-5.7 units on a scale
Standard Deviation 7.13
|
-6.3 units on a scale
Standard Deviation 7.17
|
—
|
|
Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 4
|
-0.2 units on a scale
Standard Deviation 7.13
|
-12.1 units on a scale
Standard Deviation 10.55
|
-12.5 units on a scale
Standard Deviation 11.00
|
—
|
|
Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 8
|
-1.0 units on a scale
Standard Deviation 8.99
|
-19.1 units on a scale
Standard Deviation 10.62
|
-19.2 units on a scale
Standard Deviation 11.80
|
—
|
|
Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 12
|
-0.6 units on a scale
Standard Deviation 10.62
|
-21.4 units on a scale
Standard Deviation 11.11
|
-22.4 units on a scale
Standard Deviation 11.86
|
—
|
|
Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16
Week 16
|
-0.5 units on a scale
Standard Deviation 12.39
|
-22.6 units on a scale
Standard Deviation 11.00
|
-23.9 units on a scale
Standard Deviation 12.27
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 20
|
-22.8 units on a scale
Standard Deviation 11.23
|
-24.3 units on a scale
Standard Deviation 12.52
|
-18.3 units on a scale
Standard Deviation 15.46
|
-11.3 units on a scale
Standard Deviation 10.33
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 24
|
-23.4 units on a scale
Standard Deviation 11.16
|
-24.7 units on a scale
Standard Deviation 12.35
|
-24.2 units on a scale
Standard Deviation 15.12
|
-18.2 units on a scale
Standard Deviation 9.56
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 28
|
-23.6 units on a scale
Standard Deviation 11.44
|
-24.5 units on a scale
Standard Deviation 12.56
|
-27.0 units on a scale
Standard Deviation 14.84
|
-20.1 units on a scale
Standard Deviation 10.52
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 32
|
-23.7 units on a scale
Standard Deviation 11.30
|
-24.7 units on a scale
Standard Deviation 12.58
|
-27.6 units on a scale
Standard Deviation 15.02
|
-21.0 units on a scale
Standard Deviation 11.05
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 36
|
-23.6 units on a scale
Standard Deviation 11.38
|
-24.3 units on a scale
Standard Deviation 12.72
|
-28.0 units on a scale
Standard Deviation 15.02
|
-21.5 units on a scale
Standard Deviation 10.37
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 40
|
-23.7 units on a scale
Standard Deviation 11.51
|
-24.6 units on a scale
Standard Deviation 12.29
|
-28.4 units on a scale
Standard Deviation 14.96
|
-21.7 units on a scale
Standard Deviation 10.65
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 44
|
-23.5 units on a scale
Standard Deviation 11.69
|
-24.3 units on a scale
Standard Deviation 12.29
|
-28.5 units on a scale
Standard Deviation 15.04
|
-21.6 units on a scale
Standard Deviation 10.55
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 48
|
-23.4 units on a scale
Standard Deviation 11.59
|
-24.6 units on a scale
Standard Deviation 12.27
|
-28.7 units on a scale
Standard Deviation 14.90
|
-21.6 units on a scale
Standard Deviation 10.78
|
|
Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52
Week 52
|
-23.5 units on a scale
Standard Deviation 11.74
|
-24.6 units on a scale
Standard Deviation 12.11
|
-28.5 units on a scale
Standard Deviation 15.07
|
-21.5 units on a scale
Standard Deviation 10.62
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48
|
-31.7 Change in BSA (% points)
Standard Deviation 22.40
|
-34.4 Change in BSA (% points)
Standard Deviation 21.19
|
-37.1 Change in BSA (% points)
Standard Deviation 22.24
|
-27.7 Change in BSA (% points)
Standard Deviation 16.08
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Population included participants randomized at Week 0 and with nail psoriasis at baseline.
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Outcome measures
| Measure |
Placebo (CP)
n=42 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=44 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=40 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16
|
-0.2 units on a scale
Standard Deviation 1.13
|
-1.2 units on a scale
Standard Deviation 1.61
|
-1.5 units on a scale
Standard Deviation 1.78
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 36, 48, 52Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Outcome measures
| Measure |
Placebo (CP)
n=44 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=40 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=15 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=18 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 28
|
-2.2 units on a scale
Standard Deviation 1.79
|
-2.4 units on a scale
Standard Deviation 2.34
|
-1.7 units on a scale
Standard Deviation 1.40
|
-0.7 units on a scale
Standard Deviation 1.13
|
|
Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 36
|
-2.3 units on a scale
Standard Deviation 2.01
|
-2.7 units on a scale
Standard Deviation 2.23
|
-2.5 units on a scale
Standard Deviation 1.77
|
-1.2 units on a scale
Standard Deviation 1.50
|
|
Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 48
|
-2.7 units on a scale
Standard Deviation 1.91
|
-2.7 units on a scale
Standard Deviation 2.44
|
-3.3 units on a scale
Standard Deviation 2.22
|
-1.7 units on a scale
Standard Deviation 1.75
|
|
Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 52
|
-2.8 units on a scale
Standard Deviation 1.94
|
-2.7 units on a scale
Standard Deviation 2.20
|
-3.3 units on a scale
Standard Deviation 2.34
|
-1.4 units on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Population included participants randomized at Week 0 and with nail psoriasis at baseline.
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Outcome measures
| Measure |
Placebo (CP)
n=42 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=44 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=40 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in NAPSI Score at Week 16
|
1.0 percent change
Standard Deviation 59.38
|
31.6 percent change
Standard Deviation 43.56
|
39.1 percent change
Standard Deviation 48.93
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 36, 48, 52Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with nail psoriasis at baseline.
NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Outcome measures
| Measure |
Placebo (CP)
n=44 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=40 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=15 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=18 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 28
|
57.9 percent change
Standard Deviation 42.99
|
61.1 percent change
Standard Deviation 43.15
|
48.7 percent change
Standard Deviation 38.77
|
23.6 percent change
Standard Deviation 49.69
|
|
Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 36
|
59.6 percent change
Standard Deviation 46.95
|
67.4 percent change
Standard Deviation 45.44
|
69.9 percent change
Standard Deviation 30.48
|
38.4 percent change
Standard Deviation 40.34
|
|
Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 48
|
71.0 percent change
Standard Deviation 37.11
|
68.1 percent change
Standard Deviation 49.01
|
80.2 percent change
Standard Deviation 23.06
|
53.7 percent change
Standard Deviation 42.99
|
|
Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52
Week 52
|
74.4 percent change
Standard Deviation 35.11
|
75.3 percent change
Standard Deviation 41.32
|
79.2 percent change
Standard Deviation 25.62
|
44.9 percent change
Standard Deviation 53.56
|
SECONDARY outcome
Timeframe: Week 16Population: Population included participants randomized at Week 0 and with baseline ss-IGA score \>= 2.
The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of \>= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Outcome measures
| Measure |
Placebo (CP)
n=57 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=58 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=58 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16
|
10.5 percentage of participants
|
74.1 percentage of participants
|
82.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 28, 48 and 52Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score \>= 2.
The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of \>= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Outcome measures
| Measure |
Placebo (CP)
n=58 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=58 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=21 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=24 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52
Week 28
|
86.2 percentage of participants
|
86.2 percentage of participants
|
90.5 percentage of participants
|
70.8 percentage of participants
|
|
Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52
Week 48
|
84.5 percentage of participants
|
84.5 percentage of participants
|
85.7 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52
Week 52
|
84.5 percentage of participants
|
86.2 percentage of participants
|
85.7 percentage of participants
|
95.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Population included participants randomized at Week 0 and with baseline ss-IGA score \>= 2.
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Outcome measures
| Measure |
Placebo (CP)
n=57 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=58 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=58 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
Absence of Disease (0)
|
3.5 percentage of participants
|
48.3 percentage of participants
|
63.8 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
Very Mild Disease (1)
|
8.8 percentage of participants
|
41.4 percentage of participants
|
22.4 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
Mild Disease (2)
|
21.1 percentage of participants
|
8.6 percentage of participants
|
8.6 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
Moderate Disease (3)
|
49.1 percentage of participants
|
1.7 percentage of participants
|
5.2 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16
Severe Disease (4)
|
17.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 28, 48 and 52Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline ss-IGA score \>= 2
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).
Outcome measures
| Measure |
Placebo (CP)
n=58 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=58 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=21 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=24 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 28: Absence of Disease (0)
|
63.8 percentage of participants
|
70.7 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 28: Very Mild Disease (1)
|
31.0 percentage of participants
|
22.4 percentage of participants
|
28.6 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 28: Mild Disease (2)
|
3.4 percentage of participants
|
3.4 percentage of participants
|
4.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 28: Moderate Disease (3)
|
1.7 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 28: Severe Disease (4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 48: Absence of Disease (0)
|
67.2 percentage of participants
|
75.9 percentage of participants
|
76.2 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 48: Very Mild Disease (1)
|
25.9 percentage of participants
|
13.8 percentage of participants
|
9.5 percentage of participants
|
20.8 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 48: Mild Disease (2)
|
5.2 percentage of participants
|
6.9 percentage of participants
|
9.5 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 48: Moderate Disease (3)
|
1.7 percentage of participants
|
3.4 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 48: Severe Disease (4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 52: Absence of Disease (0)
|
67.2 percentage of participants
|
77.6 percentage of participants
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 52: Very Mild Disease (1)
|
27.6 percentage of participants
|
10.3 percentage of participants
|
19.0 percentage of participants
|
20.8 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 52: Mild Disease (2)
|
3.4 percentage of participants
|
10.3 percentage of participants
|
14.3 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 52: Moderate Disease (3)
|
1.7 percentage of participants
|
1.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52
Week 52: Severe Disease (4)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 8 and 16Population: Population included participants randomized at Week 0 and with baseline DLQI \> 1.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo (CP)
n=61 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=64 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=60 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16
Week 8
|
6.6 percentage of participants
|
43.8 percentage of participants
|
43.3 percentage of participants
|
—
|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16
Week 16
|
6.6 percentage of participants
|
64.1 percentage of participants
|
68.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 28, 36, 48, and 52Population: Population included participants randomized to Guselkumab at Week 0 or 16 and with baseline DLQI \<=1.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=60 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=24 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=25 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
Week 48
|
73.4 percentage of participants
|
73.3 percentage of participants
|
62.5 percentage of participants
|
72.0 percentage of participants
|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
Week 52
|
73.4 percentage of participants
|
76.7 percentage of participants
|
75.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
Week 28
|
70.3 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
68.0 percentage of participants
|
|
Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52
Week 36
|
79.7 percentage of participants
|
83.3 percentage of participants
|
79.2 percentage of participants
|
68.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the DLQI Total Score at Week 8
|
-0.4 units on a scale
Standard Deviation 4.71
|
-7.5 units on a scale
Standard Deviation 5.28
|
-7.0 units on a scale
Standard Deviation 6.35
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 36, 48, 52Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
Week 28
|
-9.0 units on a scale
Standard Deviation 5.85
|
-8.9 units on a scale
Standard Deviation 6.95
|
-9.5 units on a scale
Standard Deviation 7.73
|
-5.5 units on a scale
Standard Deviation 5.19
|
|
Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
Week 36
|
-9.2 units on a scale
Standard Deviation 6.44
|
-9.2 units on a scale
Standard Deviation 7.27
|
-10.3 units on a scale
Standard Deviation 8.01
|
-6.1 units on a scale
Standard Deviation 5.99
|
|
Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
Week 48
|
-9.2 units on a scale
Standard Deviation 6.20
|
-9.1 units on a scale
Standard Deviation 7.12
|
-10.1 units on a scale
Standard Deviation 7.94
|
-6.1 units on a scale
Standard Deviation 5.82
|
|
Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52
Week 52
|
-9.2 units on a scale
Standard Deviation 6.39
|
-9.0 units on a scale
Standard Deviation 7.28
|
-10.1 units on a scale
Standard Deviation 7.79
|
-6.5 units on a scale
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: Weeks 8 and 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16
Week 8
|
17.2 percentage of participants
|
61.5 percentage of participants
|
58.7 percentage of participants
|
—
|
|
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16
Week 16
|
20.3 percentage of participants
|
67.7 percentage of participants
|
69.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 28, 36, 48, and 52Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
Week 28
|
69.2 percentage of participants
|
73.0 percentage of participants
|
65.4 percentage of participants
|
57.7 percentage of participants
|
|
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
Week 36
|
72.3 percentage of participants
|
68.3 percentage of participants
|
69.2 percentage of participants
|
57.7 percentage of participants
|
|
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
Week 48
|
72.3 percentage of participants
|
71.4 percentage of participants
|
69.2 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52
Week 52
|
72.3 percentage of participants
|
71.4 percentage of participants
|
69.2 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16
|
0.05 units on a scale
Standard Deviation 0.141
|
0.20 units on a scale
Standard Deviation 0.199
|
0.18 units on a scale
Standard Deviation 0.210
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 48Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48
Week 28
|
0.20 units on a scale
Standard Deviation 0.187
|
0.20 units on a scale
Standard Deviation 0.221
|
0.25 units on a scale
Standard Deviation 0.170
|
0.14 units on a scale
Standard Deviation 0.133
|
|
Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48
Week 48
|
0.20 units on a scale
Standard Deviation 0.198
|
0.21 units on a scale
Standard Deviation 0.228
|
0.28 units on a scale
Standard Deviation 0.152
|
0.15 units on a scale
Standard Deviation 0.140
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16
|
2.45 units on a scale
Standard Deviation 22.440
|
21.20 units on a scale
Standard Deviation 23.542
|
18.43 units on a scale
Standard Deviation 26.206
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 48Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48
Week 28
|
22.94 units on a scale
Standard Deviation 24.759
|
20.87 units on a scale
Standard Deviation 26.465
|
20.73 units on a scale
Standard Deviation 20.095
|
11.62 units on a scale
Standard Deviation 26.831
|
|
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48
Week 48
|
20.88 units on a scale
Standard Deviation 29.647
|
21.70 units on a scale
Standard Deviation 26.577
|
20.38 units on a scale
Standard Deviation 22.094
|
7.00 units on a scale
Standard Deviation 29.490
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16
PCS
|
0.3 units on a scale
Standard Deviation 9.90
|
7.4 units on a scale
Standard Deviation 15.65
|
7.3 units on a scale
Standard Deviation 14.40
|
—
|
|
Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16
MCS
|
1.3 units on a scale
Standard Deviation 8.21
|
4.0 units on a scale
Standard Deviation 7.22
|
5.3 units on a scale
Standard Deviation 9.63
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 48Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment.
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
Week 28: PCS
|
7.7 units on a scale
Standard Deviation 13.71
|
8.9 units on a scale
Standard Deviation 14.83
|
6.4 units on a scale
Standard Deviation 10.20
|
5.4 units on a scale
Standard Deviation 9.80
|
|
Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
Week 48: PCS
|
8.2 units on a scale
Standard Deviation 14.22
|
8.4 units on a scale
Standard Deviation 15.16
|
8.8 units on a scale
Standard Deviation 12.13
|
4.4 units on a scale
Standard Deviation 7.60
|
|
Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
Week 28: MCS
|
5.9 units on a scale
Standard Deviation 9.62
|
4.6 units on a scale
Standard Deviation 10.30
|
6.5 units on a scale
Standard Deviation 6.91
|
4.9 units on a scale
Standard Deviation 9.83
|
|
Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48
Week 48: MCS
|
5.7 units on a scale
Standard Deviation 9.04
|
5.6 units on a scale
Standard Deviation 9.32
|
4.5 units on a scale
Standard Deviation 9.92
|
5.0 units on a scale
Standard Deviation 11.00
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The randomized analysis set included all randomized participants at Week 0, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.
Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Week 16 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Outcome measures
| Measure |
Placebo (CP)
n=64 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
Absenteeism
|
0.9 units on a scale
Standard Deviation 14.96
|
-2.4 units on a scale
Standard Deviation 8.14
|
-1.9 units on a scale
Standard Deviation 8.18
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
Activity Impairment
|
-7.7 units on a scale
Standard Deviation 24.09
|
-30.9 units on a scale
Standard Deviation 31.95
|
-33.8 units on a scale
Standard Deviation 33.91
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
Presenteeism
|
-7.2 units on a scale
Standard Deviation 22.62
|
-22.0 units on a scale
Standard Deviation 34.06
|
-23.7 units on a scale
Standard Deviation 30.92
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16
Work Productivity Loss
|
-7.6 units on a scale
Standard Deviation 23.24
|
-23.0 units on a scale
Standard Deviation 34.38
|
-24.1 units on a scale
Standard Deviation 31.79
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 48Population: The analysis population for this time frame included all participants who were randomized to Guselkumab at Week 0 or 16, regardless of whether or not they received the study treatment and had any postbaseline efficacy assessment. Here 'n' signifies the number of participants analyzed for specified category.
Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Weeks 28 and 48 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Outcome measures
| Measure |
Placebo (CP)
n=65 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=63 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=26 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 28: Absenteeism
|
-3.0 units on a scale
Standard Deviation 10.93
|
-2.8 units on a scale
Standard Deviation 9.12
|
-4.0 units on a scale
Standard Deviation 8.78
|
-0.1 units on a scale
Standard Deviation 2.03
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 28: Activity Impairment
|
-35.1 units on a scale
Standard Deviation 32.02
|
-33.5 units on a scale
Standard Deviation 32.19
|
-32.7 units on a scale
Standard Deviation 29.20
|
-28.1 units on a scale
Standard Deviation 28.85
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 28: Presenteeism
|
-26.9 units on a scale
Standard Deviation 30.83
|
-24.5 units on a scale
Standard Deviation 34.43
|
-27.1 units on a scale
Standard Deviation 25.62
|
-18.7 units on a scale
Standard Deviation 26.85
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 28: Work Productivity Loss
|
-28.1 units on a scale
Standard Deviation 31.18
|
-25.1 units on a scale
Standard Deviation 35.05
|
-28.3 units on a scale
Standard Deviation 26.61
|
-18.3 units on a scale
Standard Deviation 26.68
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 48: Absenteeism
|
-2.0 units on a scale
Standard Deviation 6.56
|
-2.9 units on a scale
Standard Deviation 9.37
|
-4.5 units on a scale
Standard Deviation 9.02
|
0.7 units on a scale
Standard Deviation 2.49
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 48: Activity Impairment
|
-38.0 units on a scale
Standard Deviation 30.58
|
-36.8 units on a scale
Standard Deviation 31.72
|
-36.2 units on a scale
Standard Deviation 28.44
|
-25.0 units on a scale
Standard Deviation 30.50
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 48: Presenteeism
|
-29.3 units on a scale
Standard Deviation 31.25
|
-30.8 units on a scale
Standard Deviation 30.97
|
-30.0 units on a scale
Standard Deviation 29.93
|
-20.4 units on a scale
Standard Deviation 27.88
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48
Week 48: Work Productivity Loss
|
-29.6 units on a scale
Standard Deviation 31.88
|
-31.4 units on a scale
Standard Deviation 31.71
|
-31.5 units on a scale
Standard Deviation 30.93
|
-19.2 units on a scale
Standard Deviation 27.84
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 16Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.
ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Outcome measures
| Measure |
Placebo (CP)
n=10 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=11 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 4: ACR 20 responders
|
0 percentage of participants
|
27.3 percentage of participants
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 4: ACR 50 responders
|
0 percentage of participants
|
18.2 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 4: ACR 70 responders
|
0 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 8: ACR 20 responders
|
10.0 percentage of participants
|
45.5 percentage of participants
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 8: ACR 50 responders
|
0 percentage of participants
|
36.4 percentage of participants
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 8: ACR 70 responders
|
0 percentage of participants
|
18.2 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 16: ACR 20 responders
|
0 percentage of participants
|
45.5 percentage of participants
|
30.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 16: ACR 50 responders
|
0 percentage of participants
|
18.2 percentage of participants
|
30.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16
Week 16: ACR 70 responders
|
0 percentage of participants
|
9.1 percentage of participants
|
30.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 28, 36, 48, and 52Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.
ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Outcome measures
| Measure |
Placebo (CP)
n=11 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=3 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=4 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 28: ACR 20 responders
|
36.4 percentage of participants
|
40.0 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 28: ACR 50 responders
|
27.3 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 28: ACR 70 responders
|
18.2 percentage of participants
|
30.0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 36: ACR 20 responders
|
45.5 percentage of participants
|
40.0 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 36: ACR 50 responders
|
36.4 percentage of participants
|
40.0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 36: ACR 70 responders
|
27.3 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 48: ACR 20 responders
|
45.5 percentage of participants
|
30.0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 48: ACR 50 responders
|
45.5 percentage of participants
|
30.0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 48: ACR 70 responders
|
36.4 percentage of participants
|
30.0 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 52: ACR 20 responders
|
54.5 percentage of participants
|
20.0 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 52: ACR 50 responders
|
36.4 percentage of participants
|
20.0 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52
Week 52: ACR 70 responders
|
27.3 percentage of participants
|
20.0 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 16Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here 'n' (number analyzed) signifies the number of participants analyzed for specified category.
Percent change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Outcome measures
| Measure |
Placebo (CP)
n=10 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=11 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 4: Tender joints
|
-7.4 percent change
Standard Deviation 22.22
|
41.1 percent change
Standard Deviation 34.47
|
-8.8 percent change
Standard Deviation 117.56
|
—
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 4: Swollen joints
|
14.1 percent change
Standard Deviation 35.00
|
20.5 percent change
Standard Deviation 39.50
|
22.2 percent change
Standard Deviation 32.77
|
—
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 8: Tender joints
|
-54.6 percent change
Standard Deviation 188.70
|
47.3 percent change
Standard Deviation 39.61
|
50.1 percent change
Standard Deviation 58.06
|
—
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 8: Swollen joints
|
29.5 percent change
Standard Deviation 39.76
|
56.0 percent change
Standard Deviation 42.33
|
50.0 percent change
Standard Deviation 40.82
|
—
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 16: Tender joints
|
-60.2 percent change
Standard Deviation 86.58
|
47.0 percent change
Standard Deviation 40.12
|
22.7 percent change
Standard Deviation 126.76
|
—
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 16: Swollen joints
|
22.7 percent change
Standard Deviation 52.66
|
55.7 percent change
Standard Deviation 46.71
|
79.2 percent change
Standard Deviation 40.05
|
—
|
SECONDARY outcome
Timeframe: Weeks 28, 36, 48, and 52Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.
Percent change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Outcome measures
| Measure |
Placebo (CP)
n=11 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=3 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=4 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 28: Tender joints
|
54.9 percent change
Standard Deviation 41.34
|
60.6 percent change
Standard Deviation 46.80
|
33.3 percent change
Standard Deviation 76.38
|
-100.0 percent change
Standard Deviation 81.65
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 28: Swollen joint
|
66.0 percent change
Standard Deviation 39.14
|
94.4 percent change
Standard Deviation 8.61
|
66.1 percent change
Standard Deviation 29.36
|
43.3 percent change
Standard Deviation 60.28
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 36: Tender joints
|
69.7 percent change
Standard Deviation 40.66
|
62.1 percent change
Standard Deviation 47.33
|
33.3 percent change
Standard Deviation 76.38
|
25.0 percent change
Standard Deviation 95.74
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 36: Swollen joint
|
55.2 percent change
Standard Deviation 64.82
|
94.4 percent change
Standard Deviation 13.61
|
84.7 percent change
Standard Deviation 16.84
|
63.3 percent change
Standard Deviation 32.15
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 48: Tender joints
|
53.9 percent change
Standard Deviation 61.03
|
45.4 percent change
Standard Deviation 73.14
|
50.0 percent change
Standard Deviation 86.60
|
25.0 percent change
Standard Deviation 95.74
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 48: Swollen joint
|
72.4 percent change
Standard Deviation 42.84
|
80.6 percent change
Standard Deviation 34.02
|
82.8 percent change
Standard Deviation 13.98
|
70.0 percent change
Standard Deviation 26.46
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 52: Tender joints
|
67.8 percent change
Standard Deviation 47.31
|
32.9 percent change
Standard Deviation 72.40
|
66.7 percent change
Standard Deviation 57.74
|
75.0 percent change
Standard Deviation 50.00
|
|
Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 52: Swollen joint
|
84.5 percent change
Standard Deviation 32.70
|
58.3 percent change
Standard Deviation 55.53
|
88.9 percent change
Standard Deviation 19.25
|
86.7 percent change
Standard Deviation 23.09
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 16Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.
Change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.
Outcome measures
| Measure |
Placebo (CP)
n=10 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=11 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 4: Tender joints
|
0.2 joints
Standard Deviation 0.63
|
-3.8 joints
Standard Deviation 6.15
|
-1.6 joints
Standard Deviation 4.74
|
—
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 4: Swollen joints
|
-0.4 joints
Standard Deviation 0.97
|
-1.2 joints
Standard Deviation 2.44
|
-0.4 joints
Standard Deviation 1.58
|
—
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 8: Tender joints
|
0.9 joints
Standard Deviation 3.38
|
-4.9 joints
Standard Deviation 9.24
|
-2.6 joints
Standard Deviation 4.79
|
—
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 8: Swollen joints
|
-1.9 joints
Standard Deviation 4.68
|
-2.1 joints
Standard Deviation 2.55
|
-2.2 joints
Standard Deviation 3.43
|
—
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 16: Tender joints
|
1.3 joints
Standard Deviation 2.06
|
-3.9 joints
Standard Deviation 6.32
|
-3.3 joints
Standard Deviation 5.17
|
—
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16
Week 16: Swollen joints
|
-1.3 joints
Standard Deviation 3.56
|
-2.3 joints
Standard Deviation 3.41
|
-3.2 joints
Standard Deviation 4.37
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 36, 48, 52Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here 'n' signifies the number of participants analyzed for specified category.
Change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.
Outcome measures
| Measure |
Placebo (CP)
n=11 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=3 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=4 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 52: Swollen joint
|
-3.2 joints
Standard Deviation 3.43
|
-1.5 joints
Standard Deviation 4.09
|
-12.7 joints
Standard Deviation 10.26
|
-1.5 joints
Standard Deviation 1.29
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 28: Tender joints
|
-4.0 joints
Standard Deviation 6.03
|
-4.1 joints
Standard Deviation 5.93
|
-1.0 joints
Standard Deviation 2.00
|
1.8 joints
Standard Deviation 1.71
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 28: Swollen joint
|
-2.5 joints
Standard Deviation 2.81
|
-3.4 joints
Standard Deviation 4.35
|
-9.7 joints
Standard Deviation 8.02
|
-0.3 joints
Standard Deviation 0.96
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 36: Tender joints
|
-3.8 joints
Standard Deviation 6.23
|
-4.0 joints
Standard Deviation 5.08
|
-1.0 joints
Standard Deviation 2.00
|
-1.0 joints
Standard Deviation 2.16
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 36: Swollen joint
|
-2.8 joints
Standard Deviation 3.46
|
-3.6 joints
Standard Deviation 4.79
|
-11.7 joints
Standard Deviation 8.62
|
-1.0 joints
Standard Deviation 0.82
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 48: Tender joints
|
-3.3 joints
Standard Deviation 7.18
|
-3.0 joints
Standard Deviation 4.83
|
-1.3 joints
Standard Deviation 2.08
|
-1.0 joints
Standard Deviation 2.16
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 48: Swollen joint
|
-2.9 joints
Standard Deviation 3.30
|
-2.5 joints
Standard Deviation 3.87
|
-11.7 joints
Standard Deviation 9.29
|
-1.3 joints
Standard Deviation 1.26
|
|
Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52
Week 52: Tender joints
|
-7.0 joints
Standard Deviation 11.19
|
-2.9 joints
Standard Deviation 4.58
|
-1.7 joints
Standard Deviation 1.53
|
-1.5 joints
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 16Population: Population included randomized participants at Week 0 and who had diagnosis of PsA at screening. Participants were analyzed according to assigned treatment they were randomized to, regardless of treatment they actually received. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 4, 8 and 16 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 millimeter (mm) (no pain) to 100 mm (the worst pain imaginable).
Outcome measures
| Measure |
Placebo (CP)
n=10 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=11 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=7 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16
Week 4
|
13.70 percent change
Standard Deviation 23.698
|
3.99 percent change
Standard Deviation 78.918
|
10.32 percent change
Standard Deviation 118.053
|
—
|
|
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16
Week 8
|
2.36 percent change
Standard Deviation 37.869
|
38.19 percent change
Standard Deviation 43.951
|
45.15 percent change
Standard Deviation 55.679
|
—
|
|
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16
Week 16
|
-0.73 percent change
Standard Deviation 33.066
|
45.51 percent change
Standard Deviation 34.419
|
62.11 percent change
Standard Deviation 41.719
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 36, 48, 52Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 28, 36, 48 and 52 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Outcome measures
| Measure |
Placebo (CP)
n=11 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=7 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=3 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=4 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
Week 28
|
-37.67 Percent change
Standard Deviation 339.724
|
73.28 Percent change
Standard Deviation 28.687
|
51.18 Percent change
Standard Deviation 30.418
|
40.96 Percent change
Standard Deviation 73.340
|
|
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
Week 36
|
-26.65 Percent change
Standard Deviation 273.745
|
68.21 Percent change
Standard Deviation 40.538
|
71.92 Percent change
Standard Deviation 21.156
|
47.37 Percent change
Standard Deviation 46.079
|
|
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
Week 48
|
50.38 Percent change
Standard Deviation 74.874
|
57.65 Percent change
Standard Deviation 34.861
|
81.36 Percent change
Standard Deviation 12.019
|
74.08 Percent change
Standard Deviation 14.330
|
|
Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52
Week 52
|
-30.54 Percent change
Standard Deviation 305.279
|
62.09 Percent change
Standard Deviation 40.678
|
77.06 Percent change
Standard Deviation 23.487
|
61.47 Percent change
Standard Deviation 67.467
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 16Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 centimeter \[cm\]) to "very poor" (10 cm).
Outcome measures
| Measure |
Placebo (CP)
n=10 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=11 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=6 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16
Week 4
|
12.55 percent change
Standard Deviation 24.547
|
39.64 percent change
Standard Deviation 38.514
|
58.81 percent change
Standard Deviation 29.281
|
—
|
|
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16
Week 8
|
2.50 percent change
Standard Deviation 34.402
|
44.50 percent change
Standard Deviation 39.328
|
63.10 percent change
Standard Deviation 42.085
|
—
|
|
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16
Week 16
|
-6.52 percent change
Standard Deviation 28.037
|
21.38 percent change
Standard Deviation 71.545
|
75.70 percent change
Standard Deviation 34.106
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 28, 36, 48, 52Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 cm) to "very poor" (10 cm).
Outcome measures
| Measure |
Placebo (CP)
n=11 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=6 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=3 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=4 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
Week 48
|
43.09 percent change
Standard Deviation 109.254
|
58.36 percent change
Standard Deviation 41.137
|
76.02 percent change
Standard Deviation 24.470
|
67.60 percent change
Standard Deviation 20.616
|
|
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
Week 28
|
-46.83 percent change
Standard Deviation 346.499
|
71.26 percent change
Standard Deviation 35.552
|
45.85 percent change
Standard Deviation 35.019
|
61.23 percent change
Standard Deviation 16.062
|
|
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
Week 36
|
-48.87 percent change
Standard Deviation 341.563
|
75.55 percent change
Standard Deviation 33.992
|
51.95 percent change
Standard Deviation 27.007
|
54.46 percent change
Standard Deviation 27.386
|
|
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52
Week 52
|
-20.17 percent change
Standard Deviation 298.482
|
66.00 percent change
Standard Deviation 36.151
|
71.59 percent change
Standard Deviation 34.140
|
69.10 percent change
Standard Deviation 47.796
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 16Population: Population included randomized participants at Week 0 and who had a diagnosis of PsA at screening.
HAQ-DI response was defined as change of less than or equal to (\<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 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, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Outcome measures
| Measure |
Placebo (CP)
n=10 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=11 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16
Week 4
|
10.0 percentage of participants
|
36.4 percentage of participants
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16
Week 8
|
20.0 percentage of participants
|
45.5 percentage of participants
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16
Week 16
|
0 percentage of participants
|
54.5 percentage of participants
|
30.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 28, 36, 48, 52Population: Population included participants who were randomized to Guselkumab at Week 0 or 16 and had a diagnosis of PsA at screening.
HAQ-DI response was defined as change of less than or equal to (\<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 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, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).
Outcome measures
| Measure |
Placebo (CP)
n=11 Participants
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=10 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44 after CP.
|
Guselkumab 100 mg (CP)
n=3 Participants
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12. Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44 after CP.
|
Placebo to Guselkumab 100 mg (After CP)
n=4 Participants
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
Week 28
|
45.5 percentage of participants
|
30.0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
Week 36
|
54.5 percentage of participants
|
30.0 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
Week 48
|
45.5 percentage of participants
|
20.0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52
Week 52
|
45.5 percentage of participants
|
10.0 percentage of participants
|
66.7 percentage of participants
|
25.0 percentage of participants
|
Adverse Events
Placebo (CP)
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Guselkumab 50 mg (CP)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Guselkumab 100 mg (CP)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Guselkumab 50 mg (After CP)
Serious events: 6 serious events
Other events: 56 other events
Deaths: 0 deaths
Guselkumab 100 mg (After CP)
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Placebo to Guselkumab 50 mg (After CP)
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo to Guselkumab 100 mg (After CP)
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (CP)
n=64 participants at risk
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 participants at risk
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12.
|
Guselkumab 100 mg (CP)
n=63 participants at risk
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12.
|
Guselkumab 50 mg (After CP)
n=63 participants at risk
Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44.
|
Guselkumab 100 mg (After CP)
n=62 participants at risk
Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44.
|
Placebo to Guselkumab 50 mg (After CP)
n=26 participants at risk
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 participants at risk
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Cataract
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Diabetic Retinopathy
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Glaucoma
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Macular Hole
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Rhegmatogenous Retinal Detachment
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Bacterial Prostatitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Pancreatic Abscess
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Gouty Tophus
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to the Mediastinum
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Seizure
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Thalamus Haemorrhage
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
Other adverse events
| Measure |
Placebo (CP)
n=64 participants at risk
Participants received placebo 50 milligram (mg) and 100 mg as subcutaneous (SC) injection at Week 0, Week 4, and Week 12. At Week 16, participants in the placebo group were re-randomized to receive either guselkumab 50 mg or guselkumab 100 mg, stratified by the type of psoriasis (with or without psoriatic arthritis \[PsA\]).
|
Guselkumab 50 mg (CP)
n=65 participants at risk
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 50 mg SC injection and placebo 100 mg at Week 0, Week 4, and Week 12.
|
Guselkumab 100 mg (CP)
n=63 participants at risk
Participants stratified by the type of psoriasis (with or without PsA) received guselkumab 100 mg SC injection and placebo 50 mg at Week 0, Week 4, and Week 12.
|
Guselkumab 50 mg (After CP)
n=63 participants at risk
Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 50 mg and placebo 100 mg at Weeks 20, 28, 36, and 44.
|
Guselkumab 100 mg (After CP)
n=62 participants at risk
Participants who completed CP continued to after CP period. At Week 16, participants in this group received placebo 50 mg and 100 mg to maintain blind. After Week 16, participants received guselkumab 100 mg and placebo 50 mg at Weeks 20, 28, 36, and 44.
|
Placebo to Guselkumab 50 mg (After CP)
n=26 participants at risk
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 50 mg and placebo 100 mg at Weeks 16, 20, 28, 36, and 44.
|
Placebo to Guselkumab 100 mg (After CP)
n=26 participants at risk
Participants (who received placebo in CP and re-randomized at Week 16) received guselkumab 100 mg and placebo 50 mg at Weeks 16 20, 28, 36, and 44.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection Site Erythema
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.9%
5/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.3%
7/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
15.4%
4/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Congenital, familial and genetic disorders
Dermoid Cyst
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Ear and labyrinth disorders
External Ear Inflammation
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Blepharitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Corneal Disorder
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.3%
4/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.5%
4/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Dental Caries
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.3%
4/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
8.1%
5/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
23.1%
6/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.1%
7/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Injection Site Discolouration
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Injection Site Hypertrichosis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Injection Site Hypertrophy
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Injection Site Induration
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Injection Site Pain
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.3%
4/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Injection Site Swelling
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
General disorders
Pyrexia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.5%
4/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Hepatobiliary disorders
Hepatitis Alcoholic
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Body Tinea
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
8.1%
5/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
23.1%
6/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Cystitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Helicobacter Infection
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Infectious Colitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Influenza
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
14.3%
9/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
19.2%
5/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
19.2%
5/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Lice Infestation
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
7/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
21.5%
14/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
12.7%
8/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
60.3%
38/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
50.0%
31/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
53.8%
14/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
53.8%
14/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Omphalitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Paronychia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.9%
5/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
8.1%
5/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Tinea Cruris
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.9%
5/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Tonsillitis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.5%
4/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.9%
5/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Head Injury
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Nerve Injury
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Post-Traumatic Neck Syndrome
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Blood Triglycerides Increased
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Electrocardiogram QT Prolonged
|
3.1%
2/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Liver Function Test Abnormal
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Platelet Count Decreased
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Investigations
Weight Increased
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
9.7%
6/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
15.4%
4/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
14.3%
9/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
9.7%
6/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.1%
7/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
9.7%
6/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal Papilloma
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic Keratosis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Headache
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
9.5%
6/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Post Herpetic Neuralgia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Radial Nerve Palsy
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Psychiatric disorders
Depression
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.9%
5/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
19.2%
5/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Erosion
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Paraesthesia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.9%
5/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.1%
2/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.9%
5/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.5%
4/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.3%
7/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
19.2%
5/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Hand Dermatitis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
7.7%
2/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar Pustulosis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.6%
1/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
4.8%
3/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
17.2%
11/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.2%
2/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
1.5%
1/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.3%
4/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
6.5%
4/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.5%
3/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.8%
1/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
|
Vascular disorders
Hypertension
|
3.1%
2/64 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
3.1%
2/65 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
0.00%
0/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
11.1%
7/63 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
9.7%
6/62 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
19.2%
5/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
19.2%
5/26 • Up to Week 52
The safety analysis set included all participants who received at least 1 study agent administration. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of the treatments they were randomized to.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER