Trial Outcomes & Findings for Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous (NCT NCT01368042)
NCT ID: NCT01368042
Last Updated: 2014-08-01
Results Overview
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
COMPLETED
265 participants
Baseline, 6 months post-enrollment
2014-08-01
Participant Flow
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
Participant milestones
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Overall Study
STARTED
|
265
|
|
Overall Study
COMPLETED
|
235
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Overall Study
Death
|
14
|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Transplanted
|
1
|
Baseline Characteristics
Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores
Baseline (n=253)
|
49.3 scores on a scale
Standard Deviation 30.0
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores
6 months post-enrollment (n=235)
|
56.2 scores on a scale
Standard Deviation 30.4
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores
Baseline (n=253)
|
41.5 scores on a scale
Standard Deviation 43.2
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores
6 months post-enrollment (n=232)
|
49.9 scores on a scale
Standard Deviation 46.4
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores
Baseline (n=253)
|
43.5 scores on a scale
Standard Deviation 44.4
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores
6 months post-enrollment (n=232)
|
54.2 scores on a scale
Standard Deviation 46.0
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores
Baseline (n=254)
|
50.2 scores on a scale
Standard Deviation 24.8
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores
6 months post-enrollment (n=235)
|
63.8 scores on a scale
Standard Deviation 23.6
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores
Baseline (n=254)
|
59.4 scores on a scale
Standard Deviation 22.0
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores
6 months post-enrollment (n=235)
|
68.3 scores on a scale
Standard Deviation 22.6
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores
Baseline (n=254)
|
55.9 scores on a scale
Standard Deviation 28.6
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores
6 months post-enrollment (n=235)
|
67.2 scores on a scale
Standard Deviation 28.1
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores
Baseline (n=253)
|
57.1 scores on a scale
Standard Deviation 28.9
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores
6 months post-enrollment (n=235)
|
68.5 scores on a scale
Standard Deviation 28.5
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores
Baseline (n=254)
|
38.9 scores on a scale
Standard Deviation 17.8
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores
6 months post-enrollment (n=235)
|
39.5 scores on a scale
Standard Deviation 17.2
|
PRIMARY outcome
Timeframe: Baseline, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores
Baseline (n=254)
|
50.6 scores on a scale
Standard Deviation 26.0
|
|
Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores
6 months post-enrollment (n=235)
|
65.0 scores on a scale
Standard Deviation 27.1
|
PRIMARY outcome
Timeframe: Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollmentPopulation: All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.
The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Physical Functioning Scale
|
0.67 scores on a scale/month
Interval 0.08 to 1.26
|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Role Functioning due to Physical Health Scale
|
1.31 scores on a scale/month
Interval 0.24 to 2.38
|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Role Functioning due to Emotional Problems Scale
|
1.42 scores on a scale/month
Interval 0.31 to 2.53
|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Energy/Fatigue Scale
|
1.34 scores on a scale/month
Interval 0.82 to 1.87
|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Emotional well-being
|
0.71 scores on a scale/month
Interval 0.26 to 1.16
|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Social Functioning Scale
|
1.01 scores on a scale/month
Interval 0.36 to 1.66
|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
Bodily Pain Scale
|
1.69 scores on a scale/month
Interval 1.03 to 2.34
|
|
Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey
General Health Perceptions Scale
|
0.11 scores on a scale/month
Interval -0.27 to 0.5
|
SECONDARY outcome
Timeframe: Enrollment, 6 months post-enrollmentPopulation: All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.
Urea levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)
Enrollment (n=254)
|
147.7 mg/dL
Standard Deviation 42.3
|
|
Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)
6 month post-enrollment (n=235)
|
139.9 mg/dL
Standard Deviation 43.1
|
SECONDARY outcome
Timeframe: Enrollment, 6 months post-enrollmentPopulation: All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.
Creatinine levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)
Enrollment (n=254)
|
8.0 mg/dL
Standard Deviation 2.7
|
|
Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)
6 months post-enrollment (n=235)
|
8.3 mg/dL
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Enrollment, 6 months post-enrollmentPopulation: All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.
Calcium levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)
Enrollment (n=254)
|
9.0 mg/dL
Standard Deviation 0.8
|
|
Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)
6 months post-enrollment (n=235)
|
9.1 mg/dL
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Enrollment, 6 months post-enrollmentPopulation: All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.
Phosphorous levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)
Enrollment (n=254)
|
5.2 mg/dL
Standard Deviation 1.4
|
|
Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)
6 months post-enrollment (n=234)
|
5.2 mg/dL
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Enrollment, 6 months post-enrollmentPopulation: All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.
Ca×P product levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)
Enrollment (n=254)
|
46.6 mg˄2/dL˄2
Standard Deviation 14.4
|
|
Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)
6 months post-enrollment (n=234)
|
47.1 mg˄2/dL˄2
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Enrollment, 6 monthsPopulation: All enrolled participants with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up).
PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)
Enrollment (n=250)
|
423.4 pg/mL
Standard Deviation 331.5
|
|
Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)
6 months post-enrollment (n=218)
|
390.8 pg/mL
Standard Deviation 332.6
|
SECONDARY outcome
Timeframe: Enrollment, 3 months post-enrollment, 6 months post-enrollmentPopulation: All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.
PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from enrollment (at least 1 month after starting treatment with paricalcitol iv) through 3 months post-enrollment and 6 months post-enrollment.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 Participants
All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)
|
-5.66 pg/mL per month
Interval -12.8 to 1.48
|
Adverse Events
Chronic Kidney Disease, Secondary Hyperpathyroidism
Serious adverse events
| Measure |
Chronic Kidney Disease, Secondary Hyperpathyroidism
n=254 participants at risk
All eligible patients treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
|
|---|---|
|
Investigations
Red blood cell sedimentation rate increased
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Investigations
Weight decreased
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Investigations
White blood cell count increased
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
General disorders
Pyrexia
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Cardiac disorders
Cardiac arrest
|
4.7%
12/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Cardiac disorders
Sudden death
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Investigations
Hematocrit decreased
|
1.2%
3/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Investigations
Blood parathyroid hormone decreased
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Investigations
C-reactive protein increased
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Investigations
Prothrombin time prolonged
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
General disorders
Condition aggravated
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
General disorders
Death
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
General disorders
Fatigue
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
General disorders
Inflammation
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
3/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Diarrhea
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Hematochezia
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Large intestinal polyp
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Peritoneal hemorrhage
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Vascular disorders
Ischemic stroke
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Vascular disorders
Hypertension
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Vascular disorders
Peripheral coldness
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Vascular disorders
Peripheral ischemia
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Vascular disorders
Shock
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Vascular disorders
Vasodilatation
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Infections and infestations
Sepsis
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Infections and infestations
Arteriovenous graft site abscess
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Infections and infestations
Bacteremia
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Infections and infestations
Pneumonia
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Infections and infestations
Respiratory tract infection
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Injury, poisoning and procedural complications
Fall
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Nervous system disorders
Loss of consciousness
|
0.79%
2/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Nervous system disorders
Coma
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Nervous system disorders
Dysarthria
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Nervous system disorders
Grand mal convulsion
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Nervous system disorders
Somnolence
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Renal and urinary disorders
Hematuria
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Renal and urinary disorders
Kidney rupture
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Surgical and medical procedures
Arteriovenous graft
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Surgical and medical procedures
Nephrectomy
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Hepatobiliary disorders
Ascites
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Psychiatric disorders
Agitation
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Psychiatric disorders
Communication disorder
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Psychiatric disorders
Confusional state
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.39%
1/254 • Serious adverse events were collected from enrollment to 30 days after study completion (7 months).
Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
|
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