Trial Outcomes & Findings for Treatment Trial of Subclinical Hypothyroidism in Down Syndrome (NCT NCT01832753)
NCT ID: NCT01832753
Last Updated: 2019-09-06
Results Overview
Lipid panel will be measured via fasting blood draw.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
baseline, 6 months, 12 months & 18 months
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Immediate Treatment
Subjects in this group were observed during months 0-6, were randomized to receive levothyroxine during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Delayed Treatment
Subjects in this group were observed during months 0-6, were randomized to receive placebo during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Observation Only
Subjects in this group partook in the study during the observational phase months 0-6. Subjects in this group were not randomized to either immediate or delayed treatment groups.
|
|---|---|---|---|
|
Observation Phase (Months 0-6)
STARTED
|
5
|
4
|
3
|
|
Observation Phase (Months 0-6)
COMPLETED
|
5
|
4
|
1
|
|
Observation Phase (Months 0-6)
NOT COMPLETED
|
0
|
0
|
2
|
|
Randomization Phase (Months 6-12)
STARTED
|
5
|
4
|
0
|
|
Randomization Phase (Months 6-12)
COMPLETED
|
4
|
3
|
0
|
|
Randomization Phase (Months 6-12)
NOT COMPLETED
|
1
|
1
|
0
|
|
Open Label Dose Phase (Months 12-18)
STARTED
|
3
|
3
|
0
|
|
Open Label Dose Phase (Months 12-18)
COMPLETED
|
3
|
3
|
0
|
|
Open Label Dose Phase (Months 12-18)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Trial of Subclinical Hypothyroidism in Down Syndrome
Baseline characteristics by cohort
| Measure |
Immediate Treatment
n=5 Participants
Subjects in this group were observed during months 0-6, were randomized to receive levothyroxine during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Delayed Treatment
n=4 Participants
Subjects in this group were observed during months 0-6, were randomized to receive placebo during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Observation Only
n=3 Participants
Subjects in this group partook in the study during the observational phase months 0-6. Subjects in this group were not randomized to either immediate or delayed treatment groups.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
n=5 Participants
|
11.6 years
n=7 Participants
|
16.5 years
n=5 Participants
|
14.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
BMI Percentile
|
94 Percentile
n=5 Participants
|
98 Percentile
n=7 Participants
|
98 Percentile
n=5 Participants
|
98 Percentile
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 months, 12 months & 18 monthsPopulation: 3 of the 12 participants ("Observation Only") were withdrawn prior to randomization due to normal TSH. 1 of the 4 Delayed Treatment group participants self-withdrew before their 12 month visit. 1 of the 5 Immediate Treatment participants withdrew due to elevated TSH at their 12 month visit, 1 and self-withdrew before their 12 month visit.
Lipid panel will be measured via fasting blood draw.
Outcome measures
| Measure |
Immediate Treatment
n=5 Participants
Subjects in this group were observed during months 0-6, were randomized to receive levothyroxine during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Delayed Treatment
n=4 Participants
Subjects in this group were observed during months 0-6, were randomized to receive placebo during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Observation Only
n=3 Participants
Subjects in this group partook in the study during the observational phase months 0-6. Subjects in this group were not randomized to either immediate or delayed treatment groups.
|
|---|---|---|---|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
Baseline HDL-C (mg/dL)
|
44 mg/dL
Interval 38.0 to 46.0
|
45.5 mg/dL
Interval 40.0 to 49.5
|
43 mg/dL
Interval 32.0 to 47.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
6 month HDL-C (mg/dL)
|
35 mg/dL
Interval 32.0 to 40.0
|
46.5 mg/dL
Interval 42.5 to 50.0
|
48 mg/dL
Interval 48.0 to 48.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
12 month HDL-C (mg/dL)
|
42.5 mg/dL
Interval 40.5 to 43.0
|
44 mg/dL
Interval 37.0 to 50.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
18 month HDL-C (mg/dL)
|
38 mg/dL
Interval 36.0 to 42.0
|
47 mg/dL
Interval 43.0 to 49.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
Baseline LDL-C (mg/dL)
|
101 mg/dL
Interval 91.0 to 145.0
|
108 mg/dL
Interval 82.5 to 133.5
|
95 mg/dL
Interval 89.0 to 138.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
6 month LDL-C (mg/dL)
|
117 mg/dL
Interval 116.0 to 120.0
|
96.5 mg/dL
Interval 74.5 to 134.5
|
161 mg/dL
Interval 161.0 to 161.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
12 month LDL-C (mg/dL)
|
111 mg/dL
Interval 88.0 to 139.5
|
101 mg/dL
Interval 96.0 to 133.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
18 month LDL-C (mg/dL)
|
90 mg/dL
Interval 90.0 to 104.0
|
99 mg/dL
Interval 79.0 to 148.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
Baseline nonHDL-C (mg/dL)
|
116 mg/dL
Interval 108.0 to 160.0
|
124.5 mg/dL
Interval 94.5 to 161.0
|
118 mg/dL
Interval 116.0 to 158.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
6 month nonHDL-C (mg/dL)
|
134 mg/dL
Interval 132.0 to 160.0
|
108 mg/dL
Interval 87.0 to 157.0
|
178 mg/dL
Interval 178.0 to 178.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
12 month nonHDL-C (mg/dL)
|
137.5 mg/dL
Interval 107.0 to 172.0
|
122 mg/dL
Interval 105.0 to 154.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
Baseline Cholesterol (mg/dL)
|
160 mg/dL
Interval 145.0 to 208.0
|
170 mg/dL
Interval 144.0 to 201.0
|
163 mg/dL
Interval 150.0 to 201.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
6 month Cholesterol (mg/dL)
|
172 mg/dL
Interval 159.0 to 203.0
|
156.5 mg/dL
Interval 133.0 to 203.5
|
226 mg/dL
Interval 226.0 to 226.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
12 month Cholesterol (mg/dL)
|
178.5 mg/dL
Interval 147.5 to 215.0
|
172 mg/dL
Interval 149.0 to 191.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
18 month Cholesterol (mg/dL)
|
150 mg/dL
Interval 150.0 to 217.0
|
164 mg/dL
Interval 134.0 to 214.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
18 month nonHDL-C (mg/dL)
|
112 mg/dL
Interval 108.0 to 181.0
|
115 mg/dL
Interval 87.0 to 171.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
Basline Triglycerides (mg/dL)
|
73 mg/dL
Interval 73.0 to 84.0
|
88 mg/dL
Interval 61.5 to 137.0
|
117 mg/dL
Interval 98.0 to 133.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
6 month Triglycerides (mg/dL)
|
91 mg/dL
Interval 75.0 to 96.0
|
83 mg/dL
Interval 61.0 to 116.0
|
84 mg/dL
Interval 84.0 to 84.0
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
12 month Triglycerides (mg/dL)
|
99 mg/dL
Interval 80.5 to 178.0
|
106 mg/dL
Interval 45.0 to 107.0
|
—
|
|
Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
18 month Triglycerides (mg/dL)
|
108 mg/dL
Interval 91.0 to 383.0
|
82 mg/dL
Interval 38.0 to 113.0
|
—
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 months, & 18 monthsPopulation: 3 of the 12 participants ("Observation Only") were withdrawn prior to randomization due to normal TSH. 1 of the 4 Delayed Treatment group participants self-withdrew before their 12 month visit. 1 of the 5 Immediate Treatment participants withdrew due to elevated TSH at their 12 month visit, 1 and self-withdrew before their 12 month visit.
Questionnaires will be done with participants and parents on the day of each study visit to determine body image and quality of life. The Pediatric Quality of Life (PedsQL) scale is a 5-item scale (values 1-5). 1 - "Always True", to 5 - "Never True". Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that greater scores indicate better QOL.
Outcome measures
| Measure |
Immediate Treatment
n=5 Participants
Subjects in this group were observed during months 0-6, were randomized to receive levothyroxine during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Delayed Treatment
n=4 Participants
Subjects in this group were observed during months 0-6, were randomized to receive placebo during months 6-12, and received levothyroxine as part of the open label phase months 12-18.
All doses were between between 0.5 - 1 mcg/kg/day.
|
Observation Only
n=3 Participants
Subjects in this group partook in the study during the observational phase months 0-6. Subjects in this group were not randomized to either immediate or delayed treatment groups.
|
|---|---|---|---|
|
Change in Quality of Life From Baseline at 6, 12 and 18 Months.
6 month Pediatric Quality of Life
|
66.305 Unit on a scale, linearly transformed
Interval 57.61 to 75.0
|
61.41 Unit on a scale, linearly transformed
Interval 54.35 to 93.48
|
50 Unit on a scale, linearly transformed
Interval 50.0 to 50.0
|
|
Change in Quality of Life From Baseline at 6, 12 and 18 Months.
18 month Pediatric Quality of Life
|
70.655 Unit on a scale, linearly transformed
Interval 54.35 to 86.96
|
90.22 Unit on a scale, linearly transformed
Interval 50.0 to 94.57
|
—
|
|
Change in Quality of Life From Baseline at 6, 12 and 18 Months.
Baseline Pediatric Quality of Life
|
70.65 Unit on a scale, linearly transformed
Interval 59.78 to 83.7
|
69.02 Unit on a scale, linearly transformed
Interval 54.35 to 92.39
|
52.17 Unit on a scale, linearly transformed
Interval 51.09 to 57.61
|
|
Change in Quality of Life From Baseline at 6, 12 and 18 Months.
12 month Pediatric Quality of Life
|
75 Unit on a scale, linearly transformed
Interval 64.13 to 84.78
|
76.085 Unit on a scale, linearly transformed
Interval 56.52 to 95.65
|
—
|
Adverse Events
Observation Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Randomization Phase - Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Randomization Phase - Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Open Label Treatment Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Observation Phase
n=12 participants at risk
Months 0-6
Subjects will be observed for the first 6 months of the study to ensure that the subclinical hypothyroidism is persistent. Subjects who do not have SCH at 6 months will not proceed to the treatment phase.
Subjects that have TSH \>10 mIU/L during the 6 month Observational Phase will not be considered subclinical and will not qualify to continue the study. They will be referred to an endocrinologist for treatment.
|
Randomization Phase - Placebo
n=4 participants at risk
Months 6-12
This group includes those 4 out of 12 participants that were randomized to the delayed treatment group and received placebo for months 6-12. Adverse events will be reported in this column of the table if the AEs occurred during the phase in which participants were receiving placebo.
|
Randomization Phase - Treatment
n=5 participants at risk
Months 6-12
This group includes those 5 of 12 participants that were randomized to immediate treatment. Levothyroxine dose is between 0.5 - 1 mcg/kg/day. There is 1 blood draw visit at month 7.5 (6 weeks after randomization) and 1 study visit at month 12 that will provide the opportunity for dose adjustments if needed.
From months 12-18, all subjects will receive levothyroxine. Levothyroxine dose will be between 0.5 - 1 mcg/kg/day. There will be one blood draw visit at month 13.5 that will provide the opportunity for dose adjustments if needed.
|
Open Label Treatment Phase
n=6 participants at risk
Months 12-18
6 of the starting 12 participants took part in this phase of the study; 3 from the delayed treatment aka placebo group, 3 from the immediate treatment group. From months 12-18, all subjects receive levothyroxine. Levothyroxine dose is between 0.5 - 1 mcg/kg/day. There is one blood draw visit at month 13.5 that will provide the opportunity for dose adjustments if needed.
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety Symptoms
|
0.00%
0/12 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/4 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/6 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
|
General disorders
Dry mouth
|
0.00%
0/12 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
25.0%
1/4 • Number of events 3 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/5 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/6 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
50.0%
2/4 • Number of events 2 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/6 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
|
Cardiac disorders
Racing Heart
|
0.00%
0/12 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/4 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/6 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/5 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/6 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
|
General disorders
Sleeplessness
|
0.00%
0/12 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/4 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
|
General disorders
Tired
|
0.00%
0/12 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/4 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
0.00%
0/6 • Adverse Events were collected throughout the course of the study at each study visit and weekly following randomization up to 18 months.
Adverse Events are tracked over groups divided by phase of study for the purpose of full transparency of the relationship between study drug and AEs.
|
Additional Information
Andrea Kelly, MD MSCE
The Children's Hospital of Philadelphia
Phone: 215-590-3174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place