Trial Outcomes & Findings for Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis (NCT NCT03267277)
NCT ID: NCT03267277
Last Updated: 2024-11-26
Results Overview
Calcinosis activity is defined by the metabolic activity and the inflammation associated with calcinosis. In evaluating calcinosis activity, the study physicians take into account the change in extent of calcinosis and the location of calcinosis lesions, the consistency and texture of calcinosis lesions, the presence of erythema surrounding calcinosis lesion, and any pain associated with the calcinosis lesions. A 10 cm visual analogue scale (VAS) was scored by a physician with a vertical line on the scale marking calcinosis activity where 0 cm indicates no evidence of calcinosis, and 10 cm mark indicates severe calcinosis activity. The change in calcinosis activity VAS score from week 0 to week 10 on therapy was compared to the change in calcinosis activity VAS score from week -10 to week 0 on baseline therapy. The baseline score was calculated by taking the week 0 score minus the week -10 score. The on therapy score was calculated by taking the week 10 score minus the week 0 score.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
15 participants
Primary outcome timeframe
Week 10 minus week 0 (on therapy) and week 0 minus week -10 (baseline)
Results posted on
2024-11-26
Participant Flow
15 participants were consented but one participant was a screen failure so was not enrolled to the treatment phase of the study.
Participant milestones
| Measure |
Treatment
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis
Baseline characteristics by cohort
| Measure |
Treatment
n=14 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 10 minus week 0 (on therapy) and week 0 minus week -10 (baseline)Population: The analysis only included those participants who completed 10 weeks of treatment
Calcinosis activity is defined by the metabolic activity and the inflammation associated with calcinosis. In evaluating calcinosis activity, the study physicians take into account the change in extent of calcinosis and the location of calcinosis lesions, the consistency and texture of calcinosis lesions, the presence of erythema surrounding calcinosis lesion, and any pain associated with the calcinosis lesions. A 10 cm visual analogue scale (VAS) was scored by a physician with a vertical line on the scale marking calcinosis activity where 0 cm indicates no evidence of calcinosis, and 10 cm mark indicates severe calcinosis activity. The change in calcinosis activity VAS score from week 0 to week 10 on therapy was compared to the change in calcinosis activity VAS score from week -10 to week 0 on baseline therapy. The baseline score was calculated by taking the week 0 score minus the week -10 score. The on therapy score was calculated by taking the week 10 score minus the week 0 score.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Calcinosis Activity Visual Analogue Scale Score
|
-3.45 Units on a scale
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
The Child Health Questionnaire-Parent Form 50 (CHQ-PF50) is a 50-item survey with 14 domains that parents complete to assess their child's physical and mental well-being. The change in quality of life was measured by the physical functioning domain score on the CHQ-PF50. The CHQ-PF50 physical functioning domain scale was transformed to 0 to 100 score with higher score indicating better health or more positive functioning. The change in quality of life using the CHQ-PF50 score was measured as the mean difference in scores between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Quality of Life Measured by the Child Health Questionnaire-Parent Form 50 (CHQ-PF50): Physical Function Domain
Pre-treatment
|
-1.00 Units on a scale
Standard Deviation 6.15
|
|
Change in Quality of Life Measured by the Child Health Questionnaire-Parent Form 50 (CHQ-PF50): Physical Function Domain
On treatment
|
-8.00 Units on a scale
Standard Deviation 11.60
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
36-Item Short Form Health Survey (SF-36) is a 36-item patient-reported survey of patient health status that consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The Change in quality of life measured was assessed using the general health domain of SF-36. The higher the score the less disability. The change in quality of life using the SF-36 general health domain was measured as the mean difference in scores between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain
Pre-treatment
|
2.50 Units on a scale
Standard Deviation 7.17
|
|
Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain
On treatment
|
-1.00 Units on a scale
Standard Deviation 6.15
|
|
Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain
Post treatment
|
-8.00 Units on a scale
Standard Deviation 11.60
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
The Mawdsley Calcinosis Questionnaire (MCQ) is a 17-item questionnaire scale that measures the severity and impact of calcinosis. Each item is scored on 11-point scale of 0 to 10. Total score is the the average of the cumulative measure ranging from 0-10. Higher score indicates worse severity and impact of calcinosis. Improvement of calcinosis lesions was measured by the MCQ. The change in score was measured as the mean difference between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score
Pre-treatment
|
0.33 Units on a scale
Standard Deviation 1.54
|
|
Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score
On treatment
|
-0.74 Units on a scale
Standard Deviation 2.18
|
|
Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score
Post treatment
|
-0.17 Units on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
The Skindex-29 scale is 29-item questionnaire that measures the quality of life. Each item is scored 0 (Never) to 4 (All the time). All responses are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time) and overall score is the mean of the responses. Higher score indicates more severe impact on quality of life. The change in quality of life was measured as the mean difference in Skindex-29 scores between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Quality of Life Measured by Skindex-29 Score
Pre-treatment
|
1.77 Units on a scale
Standard Deviation 6.30
|
|
Change in Quality of Life Measured by Skindex-29 Score
On treatment
|
-8.15 Units on a scale
Standard Deviation 10.63
|
|
Change in Quality of Life Measured by Skindex-29 Score
Post treatment
|
-0.38 Units on a scale
Standard Deviation 6.53
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
Manual Muscle Test-8 (MMT-8) is a measure of muscle strength. The MMT-8 uses a 10-point scale to score each muscle group, with 0 indicating extreme weakness and 10 indicating normal strength. The scores for each muscle group are then added together to get a total score ranging from 0 to 80, with higher scores indicating greater muscle strength. Change in muscle strength over time was measured as the mean difference in MMT-8 scores between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Muscle Strength Over Time Measured by Manual Muscle Test-8 (MMT-8) Score
Pre-treatment
|
-0.08 Units on a scale
Standard Deviation 3.40
|
|
Change in Muscle Strength Over Time Measured by Manual Muscle Test-8 (MMT-8) Score
On treatment
|
1.38 Units on a scale
Standard Deviation 2.79
|
|
Change in Muscle Strength Over Time Measured by Manual Muscle Test-8 (MMT-8) Score
Post treatment
|
-0.27 Units on a scale
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
Quantitative muscle assessment (QMA) tests how much force participant can be exerted by the hip abductor muscle. It is measured as the kilograms of force produced. Higher score indicates more force. Change in hip abductor muscle strength over time was measured by the quantitative muscle assessment (QMA) as the mean difference in QMA scores between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Muscle Strength Over Time Measured by Quantitative Muscle Assessment (QMA): Hip Abductor Muscle
Pre-treatment
|
0.16 Kilograms
Standard Deviation 1.26
|
|
Change in Muscle Strength Over Time Measured by Quantitative Muscle Assessment (QMA): Hip Abductor Muscle
On treatment
|
0.74 Kilograms
Standard Deviation 1.75
|
|
Change in Muscle Strength Over Time Measured by Quantitative Muscle Assessment (QMA): Hip Abductor Muscle
Post treatment
|
1.35 Kilograms
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
The Physician Global Activity (PGA) is an index that uses a 10-cm Visual Analog Scale (VAS) to score a patient's disease activity. Higher score indicates more activity. Change in myositis activity was measured as the mean difference in disease activity scores between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Myositis Activity Measured by Physician Global Activity (PGA)
Pre-treatment
|
0.36 Units on a scale
Standard Deviation 1.54
|
|
Change in Myositis Activity Measured by Physician Global Activity (PGA)
On treatment
|
-0.87 Units on a scale
Standard Deviation 1.27
|
|
Change in Myositis Activity Measured by Physician Global Activity (PGA)
Post treatment
|
-0.32 Units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
The Physician Global Damage (PGD) is an index that uses a 10-cm Visual Analog Scale (VAS) to score a patient's disease damage. Higher score indicates more global damage. Change in myositis damage was measured as the mean difference in disease damage scores between time points.
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Myositis Damage Measured by Physician Global Damage (PGD)
Pre-treatment
|
-0.02 Units on a scale
Standard Deviation 1.09
|
|
Change in Myositis Damage Measured by Physician Global Damage (PGD)
On treatment
|
-1.07 Units on a scale
Standard Deviation 1.09
|
|
Change in Myositis Damage Measured by Physician Global Damage (PGD)
Post treatment
|
-0.18 Units on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)Population: The analysis only included those participants who completed 10 weeks of treatment
Total percent of body surface area (BSA) involved with calcinosis was measured by physician assessment. Improvement of calcinosis lesions was measured as the mean difference in total percent of BSA scores between time points
Outcome measures
| Measure |
Treatment
n=13 Participants
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Change in Total Percent Body Surface Area (BSA) Involved With Calcinosis
Pre-treatment
|
2.79 percentage of Body Surface Area (BSA)
Standard Deviation 4.06
|
|
Change in Total Percent Body Surface Area (BSA) Involved With Calcinosis
On treatment
|
-10.18 percentage of Body Surface Area (BSA)
Standard Deviation 5.01
|
|
Change in Total Percent Body Surface Area (BSA) Involved With Calcinosis
Post treatment
|
-0.45 percentage of Body Surface Area (BSA)
Standard Deviation 2.24
|
Adverse Events
Treatment
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=14 participants at risk
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • Number of events 2 • 62 weeks
|
|
Infections and infestations
Catheter site infection
|
14.3%
2/14 • Number of events 2 • 62 weeks
|
|
Infections and infestations
Device related infection
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Injury, poisoning and procedural complications
Foreign body
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Lymphocyte count decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Blood calcium decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Calcium ionized decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Red blood cell count decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
Other adverse events
| Measure |
Treatment
n=14 participants at risk
Participants received intravenous sodium thiosulfate 16 g/m\^2 three times weekly for 10 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Abnormal clotting factor
|
28.6%
4/14 • Number of events 8 • 62 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
92.9%
13/14 • Number of events 146 • 62 weeks
|
|
Blood and lymphatic system disorders
Anisocytosis
|
14.3%
2/14 • Number of events 20 • 62 weeks
|
|
Blood and lymphatic system disorders
Urine analysis abnormal
|
85.7%
12/14 • Number of events 336 • 62 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
28.6%
4/14 • Number of events 46 • 62 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
64.3%
9/14 • Number of events 280 • 62 weeks
|
|
Gastrointestinal disorders
Dental caries
|
14.3%
2/14 • Number of events 2 • 62 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
7/14 • Number of events 19 • 62 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
General disorders
Hyperthermia
|
14.3%
2/14 • Number of events 2 • 62 weeks
|
|
Infections and infestations
Corona virus infection
|
21.4%
3/14 • Number of events 5 • 62 weeks
|
|
Infections and infestations
Epstein-Barr virus infection
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Infections and infestations
Hepatitis viral
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Infections and infestations
Wound infection staphylococcal
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
21.4%
3/14 • Number of events 5 • 62 weeks
|
|
Investigations
Activated partial thromboplastin time shortened
|
42.9%
6/14 • Number of events 31 • 62 weeks
|
|
Investigations
Alanine aminotransferase
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
6/14 • Number of events 31 • 62 weeks
|
|
Investigations
Albumin urine present
|
7.1%
1/14 • Number of events 4 • 62 weeks
|
|
Investigations
Aldolase increased
|
28.6%
4/14 • Number of events 10 • 62 weeks
|
|
Investigations
Anion gap
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Anion gap decreased
|
35.7%
5/14 • Number of events 20 • 62 weeks
|
|
Investigations
Anion gap increased
|
35.7%
5/14 • Number of events 56 • 62 weeks
|
|
Investigations
Antinuclear antibody increased
|
42.9%
6/14 • Number of events 6 • 62 weeks
|
|
Investigations
Antinuclear antibody positive
|
21.4%
3/14 • Number of events 4 • 62 weeks
|
|
Investigations
Aspartate aminotransferase
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Aspartate aminotransferase decreased
|
7.1%
1/14 • Number of events 13 • 62 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
35.7%
5/14 • Number of events 20 • 62 weeks
|
|
Investigations
Autoantibody positive
|
14.3%
2/14 • Number of events 3 • 62 weeks
|
|
Investigations
Basophil count decreased
|
21.4%
3/14 • Number of events 6 • 62 weeks
|
|
Investigations
Basophil count increased
|
42.9%
6/14 • Number of events 13 • 62 weeks
|
|
Investigations
Basophil percentage increased
|
50.0%
7/14 • Number of events 15 • 62 weeks
|
|
Investigations
Bilirubin urine present
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Blood albumin decreased
|
71.4%
10/14 • Number of events 131 • 62 weeks
|
|
Investigations
Basophil percentage decreased
|
21.4%
3/14 • Number of events 4 • 62 weeks
|
|
Investigations
Blood alkaline phosphatase decreased
|
28.6%
4/14 • Number of events 60 • 62 weeks
|
|
Investigations
Blood bicarbonate decreased
|
78.6%
11/14 • Number of events 103 • 62 weeks
|
|
Investigations
Blood bicarbonate increased
|
78.6%
11/14 • Number of events 196 • 62 weeks
|
|
Investigations
Blood bilirubin decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Investigations
Blood chloride decreased
|
28.6%
4/14 • Number of events 29 • 62 weeks
|
|
Investigations
Blood chloride increased
|
92.9%
13/14 • Number of events 73 • 62 weeks
|
|
Investigations
Blood cholesterol increased
|
14.3%
2/14 • Number of events 3 • 62 weeks
|
|
Investigations
Blood creatine phosphokinase decreased
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
42.9%
6/14 • Number of events 71 • 62 weeks
|
|
Investigations
Blood creatine phosphokinase MB increased
|
28.6%
4/14 • Number of events 38 • 62 weeks
|
|
Investigations
Blood creatinine decreased
|
64.3%
9/14 • Number of events 200 • 62 weeks
|
|
Investigations
Blood erythropoietin increased
|
35.7%
5/14 • Number of events 8 • 62 weeks
|
|
Investigations
Blood folate increased
|
14.3%
2/14 • Number of events 3 • 62 weeks
|
|
Investigations
Blood homocysteine increased
|
7.1%
1/14 • Number of events 3 • 62 weeks
|
|
Investigations
Blood immunoglobulin A increased
|
35.7%
5/14 • Number of events 67 • 62 weeks
|
|
Investigations
Blood immunoglobulin E increased
|
42.9%
6/14 • Number of events 109 • 62 weeks
|
|
Investigations
Blood immunoglobulin D increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Blood immunoglobulin G increased
|
71.4%
10/14 • Number of events 150 • 62 weeks
|
|
Investigations
Blood immunoglobulin M decreased
|
21.4%
3/14 • Number of events 52 • 62 weeks
|
|
Investigations
Blood insulin increased
|
35.7%
5/14 • Number of events 10 • 62 weeks
|
|
Investigations
Blood iron decreased
|
42.9%
6/14 • Number of events 11 • 62 weeks
|
|
Investigations
Blood iron increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
92.9%
13/14 • Number of events 108 • 62 weeks
|
|
Investigations
Blood magnesium increased
|
14.3%
2/14 • Number of events 5 • 62 weeks
|
|
Investigations
Blood parathyroid hormone
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Blood parathyroid hormone decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Blood parathyroid hormone increased
|
42.9%
6/14 • Number of events 10 • 62 weeks
|
|
Investigations
Blood phosphorus decreased
|
50.0%
7/14 • Number of events 112 • 62 weeks
|
|
Investigations
Blood phosphorus increased
|
42.9%
6/14 • Number of events 15 • 62 weeks
|
|
Investigations
Blood triglycerides increased
|
21.4%
3/14 • Number of events 6 • 62 weeks
|
|
Investigations
Blood urea nitrogen decreased
|
50.0%
7/14 • Number of events 97 • 62 weeks
|
|
Investigations
Blood urea nitrogen increased
|
7.1%
1/14 • Number of events 31 • 62 weeks
|
|
Investigations
Blood uric acid increased
|
28.6%
4/14 • Number of events 29 • 62 weeks
|
|
Investigations
Brain natriuretic peptide increased
|
35.7%
5/14 • Number of events 15 • 62 weeks
|
|
Investigations
C-reactive protein-high sensitivity increased
|
64.3%
9/14 • Number of events 67 • 62 weeks
|
|
Investigations
Calcium ionized decreased
|
64.3%
9/14 • Number of events 53 • 62 weeks
|
|
Investigations
Calcium ionized increased
|
28.6%
4/14 • Number of events 57 • 62 weeks
|
|
Investigations
Carbon dioxide decreased
|
78.6%
11/14 • Number of events 142 • 62 weeks
|
|
Investigations
Carbon dioxide increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Citric acid urine decreased
|
35.7%
5/14 • Number of events 13 • 62 weeks
|
|
Investigations
Citric acid urine increased
|
7.1%
1/14 • Number of events 4 • 62 weeks
|
|
Investigations
Coagulation factor VIII level increased
|
85.7%
12/14 • Number of events 32 • 62 weeks
|
|
Investigations
Creatinine urine decreased
|
92.9%
13/14 • Number of events 270 • 62 weeks
|
|
Investigations
Creatinine urine increased
|
64.3%
9/14 • Number of events 78 • 62 weeks
|
|
Investigations
Cystatin C increased
|
57.1%
8/14 • Number of events 106 • 62 weeks
|
|
Investigations
Drug level above therapeutic
|
7.1%
1/14 • Number of events 4 • 62 weeks
|
|
Investigations
Electrophoresis protein abnormal
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Eosinophil count decreased
|
57.1%
8/14 • Number of events 21 • 62 weeks
|
|
Investigations
Eosinophil count increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Eosinophil percentage decreased
|
42.9%
6/14 • Number of events 25 • 62 weeks
|
|
Investigations
Eosinophil percentage increased
|
28.6%
4/14 • Number of events 18 • 62 weeks
|
|
Investigations
Fibrin D dimer increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Fibroblast growth factor 23 increased
|
42.9%
6/14 • Number of events 8 • 62 weeks
|
|
Investigations
Flow cytometry
|
100.0%
14/14 • Number of events 42 • 62 weeks
|
|
Investigations
Glucose urine present
|
50.0%
7/14 • Number of events 133 • 62 weeks
|
|
Investigations
Glycosylated hemoglobin increased
|
21.4%
3/14 • Number of events 5 • 62 weeks
|
|
Investigations
Immature granulocyte count increased
|
71.4%
10/14 • Number of events 47 • 62 weeks
|
|
Investigations
Hemoglobin decreased
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Investigations
Hemoglobin urine present
|
42.9%
6/14 • Number of events 122 • 62 weeks
|
|
Investigations
Haptoglobin decreased
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Investigations
Haptoglobin increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Hepatitis B core antibody positive
|
21.4%
3/14 • Number of events 5 • 62 weeks
|
|
Investigations
Hepatitis B surface antigen positive
|
21.4%
3/14 • Number of events 6 • 62 weeks
|
|
Investigations
Insulin C-peptide increased
|
14.3%
2/14 • Number of events 2 • 62 weeks
|
|
Investigations
Low density lipoprotein abnormal
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Lymphocyte percentage decreased
|
42.9%
6/14 • Number of events 10 • 62 weeks
|
|
Investigations
Lymphocyte percentage increased
|
64.3%
9/14 • Number of events 35 • 62 weeks
|
|
Investigations
Mean cell hemoglobin decreased
|
14.3%
2/14 • Number of events 12 • 62 weeks
|
|
Investigations
Mean cell hemoglobin increased
|
7.1%
1/14 • Number of events 12 • 62 weeks
|
|
Investigations
Mean cell volume decreased
|
7.1%
1/14 • Number of events 11 • 62 weeks
|
|
Investigations
Mean cell volume increased
|
7.1%
1/14 • Number of events 15 • 62 weeks
|
|
Investigations
Mean platelet volume decreased
|
42.9%
6/14 • Number of events 25 • 62 weeks
|
|
Investigations
Metamyelocyte percentage increased
|
14.3%
2/14 • Number of events 5 • 62 weeks
|
|
Investigations
Monocyte percentage decreased
|
42.9%
6/14 • Number of events 15 • 62 weeks
|
|
Investigations
Monocyte percentage increased
|
21.4%
3/14 • Number of events 7 • 62 weeks
|
|
Investigations
Myelocyte percentage increased
|
28.6%
4/14 • Number of events 5 • 62 weeks
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Neutrophil percentage decreased
|
50.0%
7/14 • Number of events 20 • 62 weeks
|
|
Investigations
Neutrophil percentage increased
|
42.9%
6/14 • Number of events 12 • 62 weeks
|
|
Investigations
Nitrite urine present
|
14.3%
2/14 • Number of events 58 • 62 weeks
|
|
Investigations
PCO2 decreased
|
78.6%
11/14 • Number of events 156 • 62 weeks
|
|
Investigations
PCO2 increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
pH urine increased
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Investigations
Platelet count decreased
|
35.7%
5/14 • Number of events 24 • 62 weeks
|
|
Investigations
Platelet count increased
|
14.3%
2/14 • Number of events 17 • 62 weeks
|
|
Investigations
Platelet morphology abnormal
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
PO2 decreased
|
21.4%
3/14 • Number of events 5 • 62 weeks
|
|
Investigations
PO2 increased
|
78.6%
11/14 • Number of events 70 • 62 weeks
|
|
Investigations
Promyelocyte count increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Protein total decreased
|
28.6%
4/14 • Number of events 33 • 62 weeks
|
|
Investigations
Protein total increased
|
42.9%
6/14 • Number of events 75 • 62 weeks
|
|
Investigations
Protein urine present
|
35.7%
5/14 • Number of events 57 • 62 weeks
|
|
Investigations
Prothrombin time shortened
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Investigations
Red blood cell count decreased
|
92.9%
13/14 • Number of events 140 • 62 weeks
|
|
Investigations
Red blood cell microcytes present
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Investigations
Red blood cell morphology abnormal
|
14.3%
2/14 • Number of events 8 • 62 weeks
|
|
Investigations
Red blood cell poikilocytes present
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Red blood cell sedimentation rate
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Red blood cell sedimentation rate increased
|
57.1%
8/14 • Number of events 22 • 62 weeks
|
|
Investigations
Red blood cells urine increased
|
71.4%
10/14 • Number of events 84 • 62 weeks
|
|
Investigations
Red cell distribution width increased
|
85.7%
12/14 • Number of events 134 • 62 weeks
|
|
Investigations
Reticulocyte count decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Reticulocyte count increased
|
42.9%
6/14 • Number of events 52 • 62 weeks
|
|
Investigations
Reticulocyte hemoglobin equivalent
|
57.1%
8/14 • Number of events 23 • 62 weeks
|
|
Investigations
Reticulocyte percentage increased
|
64.3%
9/14 • Number of events 47 • 62 weeks
|
|
Investigations
Serum ferritin decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Serum ferritin increased
|
50.0%
7/14 • Number of events 21 • 62 weeks
|
|
Investigations
Specific gravity urine increased
|
14.3%
2/14 • Number of events 6 • 62 weeks
|
|
Investigations
T-lymphocyte count increased
|
7.1%
1/14 • Number of events 3 • 62 weeks
|
|
Investigations
Transferrin increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Transferrin saturation increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Urinary casts present
|
28.6%
4/14 • Number of events 14 • 62 weeks
|
|
Investigations
Urine albumin/creatinine ratio increased
|
14.3%
2/14 • Number of events 3 • 62 weeks
|
|
Investigations
Urine calcium decreased
|
35.7%
5/14 • Number of events 56 • 62 weeks
|
|
Investigations
Urine calcium increased
|
21.4%
3/14 • Number of events 14 • 62 weeks
|
|
Investigations
Urine ketone body present
|
71.4%
10/14 • Number of events 27 • 62 weeks
|
|
Investigations
Urine leukocyte esterase positive
|
57.1%
8/14 • Number of events 128 • 62 weeks
|
|
Investigations
Urine magnesium decreased
|
85.7%
12/14 • Number of events 38 • 62 weeks
|
|
Investigations
Urine magnesium increased
|
50.0%
7/14 • Number of events 19 • 62 weeks
|
|
Investigations
Urine oxalate decreased
|
42.9%
6/14 • Number of events 12 • 62 weeks
|
|
Investigations
Urine oxalate increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Urine phosphorus decreased
|
71.4%
10/14 • Number of events 14 • 62 weeks
|
|
Investigations
Urine phosphorus increased
|
42.9%
6/14 • Number of events 17 • 62 weeks
|
|
Investigations
Urine potassium decreased
|
50.0%
7/14 • Number of events 68 • 62 weeks
|
|
Investigations
Urine potassium increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Urine protein/creatinine ratio increased
|
85.7%
12/14 • Number of events 288 • 62 weeks
|
|
Investigations
Urine sodium decreased
|
14.3%
2/14 • Number of events 2 • 62 weeks
|
|
Investigations
Urine sodium increased
|
92.9%
13/14 • Number of events 36 • 62 weeks
|
|
Investigations
Urine uric acid decreased
|
14.3%
2/14 • Number of events 4 • 62 weeks
|
|
Investigations
Urine uric acid increased
|
28.6%
4/14 • Number of events 19 • 62 weeks
|
|
Investigations
Urobilinogen urine
|
14.3%
2/14 • Number of events 4 • 62 weeks
|
|
Investigations
Venous oxygen saturation decreased
|
100.0%
14/14 • Number of events 228 • 62 weeks
|
|
Investigations
Venous oxygen saturation increased
|
100.0%
14/14 • Number of events 180 • 62 weeks
|
|
Investigations
Vitamin B12 increased
|
14.3%
2/14 • Number of events 2 • 62 weeks
|
|
Investigations
Vitamin D decreased
|
71.4%
10/14 • Number of events 29 • 62 weeks
|
|
Investigations
Vitamin D increased
|
14.3%
2/14 • Number of events 4 • 62 weeks
|
|
Investigations
Von Willebrand's factor activity increased
|
42.9%
6/14 • Number of events 15 • 62 weeks
|
|
Investigations
Von Willebrand's factor antigen increased
|
28.6%
4/14 • Number of events 8 • 62 weeks
|
|
Investigations
White blood cell count decreased
|
28.6%
4/14 • Number of events 18 • 62 weeks
|
|
Investigations
White blood cell count increased
|
42.9%
6/14 • Number of events 22 • 62 weeks
|
|
Investigations
White blood cells urine increased
|
85.7%
12/14 • Number of events 134 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
2/14 • Number of events 12 • 62 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
92.9%
13/14 • Number of events 413 • 62 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
21.4%
3/14 • Number of events 8 • 62 weeks
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.1%
1/14 • Number of events 11 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
71.4%
10/14 • Number of events 146 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
64.3%
9/14 • Number of events 32 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
92.9%
13/14 • Number of events 92 • 62 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.9%
6/14 • Number of events 49 • 62 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
92.9%
13/14 • Number of events 95 • 62 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
4/14 • Number of events 4 • 62 weeks
|
|
Nervous system disorders
Headache
|
35.7%
5/14 • Number of events 21 • 62 weeks
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Urine amino acid level abnormal
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Vascular disorders
Hypertension
|
100.0%
14/14 • Number of events 422 • 62 weeks
|
|
Vascular disorders
Hypotension
|
42.9%
6/14 • Number of events 95 • 62 weeks
|
|
Investigations
Absolute lymphocyte count decreased
|
14.3%
2/14 • Number of events 17 • 62 weeks
|
|
Investigations
Absolute lymphocyte count increased
|
35.7%
5/14 • Number of events 47 • 62 weeks
|
|
Investigations
Absolute monocyte count decreased
|
28.6%
4/14 • Number of events 13 • 62 weeks
|
|
Investigations
Absolute monocyte count increased
|
28.6%
4/14 • Number of events 19 • 62 weeks
|
|
Investigations
Absolute neutrophil count decreased
|
28.6%
4/14 • Number of events 11 • 62 weeks
|
|
Investigations
Absolute neutrophil count increased
|
50.0%
7/14 • Number of events 12 • 62 weeks
|
|
Investigations
Beta 2 microglobulin urine increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Bilirubin conjugated
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Infections and infestations
Human T-cell lymphotropic virus infection
|
21.4%
3/14 • Number of events 3 • 62 weeks
|
|
Investigations
Immature granulocyte percentage increased
|
92.9%
13/14 • Number of events 71 • 62 weeks
|
|
Investigations
Ionized Magnesium decreased
|
64.3%
9/14 • Number of events 87 • 62 weeks
|
|
Investigations
Ionized Magnesium increased
|
64.3%
9/14 • Number of events 153 • 62 weeks
|
|
Investigations
Blood calcium decreased
|
7.1%
1/14 • Number of events 13 • 62 weeks
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • Number of events 10 • 62 weeks
|
|
Investigations
Blood glucose increased
|
7.1%
1/14 • Number of events 30 • 62 weeks
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
14.3%
2/14 • Number of events 6 • 62 weeks
|
|
Investigations
Blood thyroid stimulating hormone increased
|
35.7%
5/14 • Number of events 18 • 62 weeks
|
|
Infections and infestations
Catheter site infection
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Creatinine renal clearance decreased
|
71.4%
10/14 • Number of events 47 • 62 weeks
|
|
Investigations
Creatinine renal clearance increased
|
21.4%
3/14 • Number of events 9 • 62 weeks
|
|
Investigations
Cystatin C abnormal
|
7.1%
1/14 • Number of events 20 • 62 weeks
|
|
Vascular disorders
Diastolic hypertension
|
35.7%
5/14 • Number of events 30 • 62 weeks
|
|
Vascular disorders
Diastolic hypotension
|
92.9%
13/14 • Number of events 448 • 62 weeks
|
|
Investigations
Erythroblast count increased
|
50.0%
7/14 • Number of events 15 • 62 weeks
|
|
Investigations
Laboratory test
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Lipids abnormal
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Mean cell hemoglobin concentration decreased
|
78.6%
11/14 • Number of events 86 • 62 weeks
|
|
Nervous system disorders
Migraine
|
7.1%
1/14 • Number of events 2 • 62 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Nervous system disorders
Procedural dizziness
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Prothrombin time prolonged
|
14.3%
2/14 • Number of events 7 • 62 weeks
|
|
Vascular disorders
Systolic hypertension
|
100.0%
14/14 • Number of events 515 • 62 weeks
|
|
Investigations
Thyroxine decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Thyroxine free decreased
|
14.3%
2/14 • Number of events 22 • 62 weeks
|
|
Investigations
Transferrin decreased
|
14.3%
2/14 • Number of events 16 • 62 weeks
|
|
Investigations
Transferrin saturation decreased
|
50.0%
7/14 • Number of events 13 • 62 weeks
|
|
Investigations
Urea renal clearance decreased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
|
Investigations
Urine calcium oxalate
|
14.3%
2/14 • Number of events 8 • 62 weeks
|
|
Investigations
Urine protein, quantitative increased
|
92.9%
13/14 • Number of events 179 • 62 weeks
|
|
Investigations
Venous blood pH decreased
|
71.4%
10/14 • Number of events 62 • 62 weeks
|
|
Investigations
Venous blood pH increased
|
7.1%
1/14 • Number of events 1 • 62 weeks
|
Additional Information
Dr. Adam Schiffenbauer
National Institute of Environmental Health Sciences
Phone: +1 301 451 6270
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place