Trial Outcomes & Findings for Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities (NCT NCT01401452)
NCT ID: NCT01401452
Last Updated: 2017-10-04
Results Overview
The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
COMPLETED
246 participants
Baseline, Months 1, 3, 6, and 9
2017-10-04
Participant Flow
Participant milestones
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Overall Study
STARTED
|
246
|
|
Overall Study
Visit 1 (Baseline)
|
246
|
|
Overall Study
Visit 2 (1 Month)
|
225
|
|
Overall Study
Visit 3 (3 Months)
|
217
|
|
Overall Study
Visit 4 (6 Months)
|
172
|
|
Overall Study
Visit 5 (9 Months)
|
175
|
|
Overall Study
COMPLETED
|
174
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Overall Study
Adverse reaction
|
9
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Lack of Efficacy
|
30
|
|
Overall Study
Participant developed breast cancer
|
1
|
|
Overall Study
Tx stopped due to financial reasons
|
1
|
|
Overall Study
Tx stopped by psychiatrist
|
1
|
|
Overall Study
No more visits within the 36 wk followup
|
4
|
|
Overall Study
Subject did not come to follow up visits
|
2
|
|
Overall Study
Subject didn't return for routine visits
|
1
|
|
Overall Study
Subject moved to another city
|
1
|
|
Overall Study
Subject's wife wants to get pregnant
|
1
|
|
Overall Study
Psoriatic arthritis
|
1
|
|
Overall Study
Participant stopped Tx
|
2
|
|
Overall Study
Discontinuation for personal reasons
|
1
|
|
Overall Study
Treatment failure
|
1
|
|
Overall Study
Unsatisfactory output
|
1
|
|
Overall Study
Subject withdrew because of Tx success
|
1
|
|
Overall Study
Subject chose to discontinue treatment
|
1
|
|
Overall Study
Participant withdrew consent
|
1
|
Baseline Characteristics
Males and females were analyzed separately
Baseline characteristics by cohort
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=246 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 13.6 • n=246 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=246 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=246 Participants
|
|
Duration of psoriasis
|
18.6 years
STANDARD_DEVIATION 13.6 • n=246 Participants
|
|
Number of participants with comorbidities
Female
|
93 participants
n=93 Participants • Males and females were analyzed separately
|
|
Number of participants with comorbidities
Male
|
152 participants
n=153 Participants • Males and females were analyzed separately
|
|
Most prevalent co-morbidities among participants in the study
Psoriatic arthritis
|
114 participants
n=246 Participants
|
|
Most prevalent co-morbidities among participants in the study
Hypertension
|
79 participants
n=246 Participants
|
|
Most prevalent co-morbidities among participants in the study
Metabolic syndrome
|
72 participants
n=246 Participants
|
|
Most prevalent co-morbidities among participants in the study
Obesity
|
64 participants
n=246 Participants
|
|
Most prevalent co-morbidities among participants in the study
Diabetes
|
31 participants
n=246 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data
The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=208 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
1 month
|
31.3 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
3 months
|
52.8 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
6 months
|
55.8 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
9 months
|
57.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=238 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Mean Dermatology Life Quality Index (DLQI) Scores
Baseline
|
12.4 units on a scale
Standard Deviation 8.0
|
|
Mean Dermatology Life Quality Index (DLQI) Scores
1 month
|
7.2 units on a scale
Standard Deviation 7.1
|
|
Mean Dermatology Life Quality Index (DLQI) Scores
3 months
|
5.4 units on a scale
Standard Deviation 6.6
|
|
Mean Dermatology Life Quality Index (DLQI) Scores
6 months
|
4.8 units on a scale
Standard Deviation 6.0
|
|
Mean Dermatology Life Quality Index (DLQI) Scores
9 months
|
4.3 units on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data
The percentage of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=208 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
1 month
|
51.0 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
3 months
|
66.8 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
6 months
|
66.9 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
9 months
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data
The percentage of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=208 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
1 month
|
11.5 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
3 months
|
38.9 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
6 months
|
45.5 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
9 months
|
43.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data
The percentage of participants with a ≥ 100% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=208 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
1 month
|
6.3 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
3 months
|
22.3 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
6 months
|
32.5 percentage of participants
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
9 months
|
30.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data. Missing values were imputed if single answers were missing for one dimension.
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=232 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
Baseline
|
46.33 units on a scale
Standard Deviation 8.97
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
1 month
|
48.19 units on a scale
Standard Deviation 8.87
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
3 months
|
49.54 units on a scale
Standard Deviation 8.80
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
6 months
|
49.31 units on a scale
Standard Deviation 8.82
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
9 months
|
50.48 units on a scale
Standard Deviation 8.24
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data. Missing values were imputed if single answers were missing for one dimension.
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=234 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
Baseline
|
41.35 units on a scale
Standard Deviation 11.32
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
1 month
|
45.39 units on a scale
Standard Deviation 10.43
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
3 months
|
47.01 units on a scale
Standard Deviation 10.25
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
6 months
|
47.92 units on a scale
Standard Deviation 10.26
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
9 months
|
48.32 units on a scale
Standard Deviation 9.89
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 PCS was defined as an increase in PCS of at least 3 points from the baseline score.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=201 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
1 month
|
38.3 percentage of participants
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
3 months
|
52.9 percentage of participants
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
6 months
|
48.0 percentage of participants
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
9 months
|
55.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, and 9Population: Participants with available data
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 MCS was defined as an increase in MCS of at least 5 points from the baseline score.
Outcome measures
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=204 Participants
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
1 month
|
38.2 percentage of participants
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
3 months
|
49.7 percentage of participants
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
6 months
|
52.6 percentage of participants
|
|
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
9 months
|
61.9 percentage of participants
|
Adverse Events
Participants With Psoriasis and at Least One Co-morbid Disease
Serious adverse events
| Measure |
Participants With Psoriasis and at Least One Co-morbid Disease
n=246 participants at risk
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
|
|---|---|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.81%
2/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
General disorders
Puncture site erythema
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Infections and infestations
Vestibular neuronitis
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Reproductive system and breast disorders
Priapism
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
0.41%
1/246 • Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor Abbott)
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER