Trial Outcomes & Findings for RAD001 and Neurocognition in PTEN Hamartoma Tumor Syndrome (NCT NCT02991807)
NCT ID: NCT02991807
Last Updated: 2025-02-17
Results Overview
The primary endpoint will be safety as measured by study drop-out rate due to side effects, comparing everolimus vs. placebo. We will also determine the frequency of adverse events by type and severity. This section displays participant dropout rate and for what reason.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Through study completion, an average of 6 months
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
RAD001
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
RAD001
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Investigator decision at baseline given safety concerns related to drug administration compliance
|
1
|
0
|
Baseline Characteristics
RAD001 and Neurocognition in PTEN Hamartoma Tumor Syndrome
Baseline characteristics by cohort
| Measure |
RAD001
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
15.6 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Autism spectrum disorder (n)
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Autism spectrum disorder (%)
|
25 percentage of participants
n=5 Participants
|
36.3 percentage of participants
n=7 Participants
|
30.4 percentage of participants
n=5 Participants
|
|
Stanford-Binet Intelligence Scales, Fifth Edition (SB-5): Mean full scale IQ (FSIQ)
|
77.8 scores on a scale
STANDARD_DEVIATION 20.3 • n=5 Participants
|
75.2 scores on a scale
STANDARD_DEVIATION 23.5 • n=7 Participants
|
76.6 scores on a scale
STANDARD_DEVIATION 21.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 monthsThe primary endpoint will be safety as measured by study drop-out rate due to side effects, comparing everolimus vs. placebo. We will also determine the frequency of adverse events by type and severity. This section displays participant dropout rate and for what reason.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=46 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Dropout
Dropout (Total)
|
2 Participants
|
5 Participants
|
3 Participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Dropout
Dropout due to participant/parent request
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Dropout
Dropout due to investigator request
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Dropout
Dropout due to other requests
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 monthsThe primary endpoint will be safety as measured by study drop-out rate due to side effects, comparing everolimus vs. placebo. We will also determine the frequency of adverse events by type and severity. this section displays the number of participants who experienced an AE and the description of such AEs, pertaining to: 1. Seriousness 2. Grade, 3. Relation to treatment 4. Recovery from AE 5. Category
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=46 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Any AE (%)
|
59.1 percentage of participants
|
73.9 percentage of participants
|
87.5 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Non-serious AEs (%)
|
59.1 percentage of participants
|
73.9 percentage of participants
|
87.5 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Serious AEs (%)
|
0 percentage of participants
|
6.5 percentage of participants
|
12.5 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Grade 1 (%)
|
45.5 percentage of participants
|
60.9 percentage of participants
|
75 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Grade 2 (%)
|
18.2 percentage of participants
|
34.8 percentage of participants
|
50 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Grade 3 (%)
|
0 percentage of participants
|
8.7 percentage of participants
|
16.7 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Grade 4 (%)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Grade 5 (%)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Definitely not related to treatment (%)
|
27.3 percentage of participants
|
23.9 percentage of participants
|
20.8 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Probably not related to treatment (%)
|
18.2 percentage of participants
|
28.3 percentage of participants
|
37.5 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Possibly or probably related to treatment (%)
|
31.8 percentage of participants
|
52.2 percentage of participants
|
70.8 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Definitely related to treatment (%)
|
0 percentage of participants
|
6.5 percentage of participants
|
12.5 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Patients not recovered/not resolved from AEs (%)
|
4.5 percentage of participants
|
2.2 percentage of participants
|
0 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Patients recovered/resolved with sequelae form AEs (%)
|
0 percentage of participants
|
2.2 percentage of participants
|
4.2 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Patients recovered/resolved without sequelae fro AEs (%)
|
59.1 percentage of participants
|
71.7 percentage of participants
|
83.3 percentage of participants
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Adverse Events (AEs) Overview (% of Participants)
Patients recovering/resolving from AEs (%)
|
3 percentage of participants
|
4.3 percentage of participants
|
8.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsComposite score was based on the following: Stanford-Binet Intelligence Scales, 5th Ed (SB-5) non-verbal and verbal working memory standard score; for the SB-5, the minimum score is 40 and the maximum score is 160, where the higher score represents a better outcome. Conners' Continuous Performance Test, 3rd Ed (CPT-3) hit reaction time standard score (reverse coded; standard score generated from T-score); for the CPT-3, the min score is 0 and the max score is 90, where the lower the T-score, the better the outcome. Purdue Pegboard Test (PPT) both hands standard score (generated from T-score); for the PPT, the min score is 20 and the max score is 190, where the higher the T-score, the better the outcome. For the composite score, the higher the score, the better the outcome. The composite score is on the SS metric (M=100, SD=15, min=20, max=180).
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=21 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
n=20 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Change at 6 Months in Composite Score
|
75.14 score on a scale
Standard Deviation 18.30
|
81.60 score on a scale
Standard Deviation 17.17
|
80.34 score on a scale
Standard Deviation 15.23
|
78.47 score on a scale
Standard Deviation 21.96
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in processing speed scores were obtained from Conner's Continuous Performance Test (CPT)-3. Change in processing speed subscale scores were converted to standard scores, where a higher score indicates a better result (range 0-100).
Processing speed will be evaluated using mean reaction time on the Conner's Continuous Performance Test (CPT)-3. This outcome evaluates the change from baseline to 6 months.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=21 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
n=20 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Change in Processing Speed at 6 Months, Conner's Continuous Performance Test (CPT)-3
|
86.30 score on a scale
Standard Deviation 16.16
|
89.26 score on a scale
Standard Deviation 22.35
|
87.78 score on a scale
Standard Deviation 20
|
90.15 score on a scale
Standard Deviation 15.46
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in fine motor skill scores were obtained from Purdue Pegboard. Fine motor skill scores were generated using standard scores, where a higher score indicates a better result (range 0-100).
Fine motor skills will be evaluated using the Purdue Pegboard sub-tests average of both hands. This outcome evaluates the change from baseline to 6 months.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=21 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
n=20 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Change in Fine Motor Skills at 6 Months, Purdue Pegboard
|
55.92 score on a scale
Standard Deviation 23.56
|
67.12 score on a scale
Standard Deviation 20.08
|
62.83 score on a scale
Standard Deviation 20.52
|
61.49 score on a scale
Standard Deviation 33.37
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Global Cognitive Ability scores were obtained from Stanford Binet 5 or Mullen Scales of Early Learning depending on participant age and testing capability. Global Cognitive Ability subscale scores were converted to standard scores, where a higher score indicates a better result (range 0-100).
Change in global cognitive ability will be measured by Stanford-Binet 5 or Mullen; Full scale, verbal and nonverbal ability (IQ). This outcome evaluates the change from baseline to 6 months.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=21 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
n=20 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Change in Global Cognitive Ability at 6 Months, Stanford-Binet Intelligence Scales, Fifth Edition (SB-5) or Mullen Scales of Early Learning
Full Scale (FSIQ)
|
75.19 score on a scale
Standard Deviation 22.90
|
79.39 score on a scale
Standard Deviation 17.30
|
77.83 score on a scale
Standard Deviation 19.85
|
74.79 score on a scale
Standard Deviation 25.79
|
|
Change in Global Cognitive Ability at 6 Months, Stanford-Binet Intelligence Scales, Fifth Edition (SB-5) or Mullen Scales of Early Learning
Verbal (VIQ)
|
76.05 score on a scale
Standard Deviation 23.67
|
78.46 score on a scale
Standard Deviation 18.05
|
78.79 score on a scale
Standard Deviation 19.73
|
78.71 score on a scale
Standard Deviation 27.07
|
|
Change in Global Cognitive Ability at 6 Months, Stanford-Binet Intelligence Scales, Fifth Edition (SB-5) or Mullen Scales of Early Learning
Nonverbal (NVIQ)
|
75.91 score on a scale
Standard Deviation 22.70
|
82.31 score on a scale
Standard Deviation 16.25
|
78.96 score on a scale
Standard Deviation 19.03
|
73.15 score on a scale
Standard Deviation 22.87
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in motor functioning scores were obtained from Purdue Pegboard Developmental Coordination Disorder Questionnaire (DCDQ). Pegboard motor functioning scores were generated using standard scores, where a higher score indicates a better result (range 0-100). DCDQ motor functioning scores utilize the scale's total score, where higher scores indicate a better result (range 15-75).
Motor functioning will be measured by the Purdue Pegboard (Pegs): Dominant and non-dominant hand combined standard scores and Developmental Coordination Disorder Questionnaire (DCDQ): Total score. This outcome evaluates the change from baseline to 6 months.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=21 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
n=20 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Change in Motor Functioning at 6 Months, Purdue Pegboard and Developmental Coordination Disorder Questionnaire (DCDQ)
Purdue Pegboard (left hand)
|
61.82 score on a scale
Standard Deviation 20.91
|
75.92 score on a scale
Standard Deviation 24.76
|
66.46 score on a scale
Standard Deviation 23.02
|
60.26 score on a scale
Standard Deviation 29.30
|
|
Change in Motor Functioning at 6 Months, Purdue Pegboard and Developmental Coordination Disorder Questionnaire (DCDQ)
Purdue Pegboard (right hand)
|
58.64 score on a scale
Standard Deviation 27.83
|
71.68 score on a scale
Standard Deviation 30.18
|
66.92 score on a scale
Standard Deviation 22.83
|
61.47 score on a scale
Standard Deviation 35.48
|
|
Change in Motor Functioning at 6 Months, Purdue Pegboard and Developmental Coordination Disorder Questionnaire (DCDQ)
Purdue Pegboard (dominant hand)
|
58.63 score on a scale
Standard Deviation 27.91
|
75.60 score on a scale
Standard Deviation 24.78
|
67.92 score on a scale
Standard Deviation 21.92
|
59.25 score on a scale
Standard Deviation 32.48
|
|
Change in Motor Functioning at 6 Months, Purdue Pegboard and Developmental Coordination Disorder Questionnaire (DCDQ)
Purdue Pegboard (non-dominant hand)
|
61.89 score on a scale
Standard Deviation 27.91
|
75.58 score on a scale
Standard Deviation 24.78
|
69.37 score on a scale
Standard Deviation 21.92
|
62.36 score on a scale
Standard Deviation 32.48
|
|
Change in Motor Functioning at 6 Months, Purdue Pegboard and Developmental Coordination Disorder Questionnaire (DCDQ)
DCDQ Total Score
|
36.29 score on a scale
Standard Deviation 14.20
|
40.01 score on a scale
Standard Deviation 10.62
|
37.51 score on a scale
Standard Deviation 12.38
|
37.64 score on a scale
Standard Deviation 16.37
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: WRAML-2 scaled scores (range 1-19, higher = better) BRIEF-2 global executive composite standard score (range 0-100, higher = better) SRS-2 total standard score (range 0-100, higher = better) RBS-R total subscale score (range 0-56, LOWER = better) VABS-III adaptive behavior composite standard score (range 0-100, higher = better) CBCL total problems standard score (range 0-100, higher = better) SSP total score (range 38-190, higher = better)
1. Change in memory measured by Wide Range Assessment of Memory and Learning (WRAML-2) verbal learning core subtest, delayed recall, and recognition scaled scores over 6 months. 2. Change in executive functioning measured by Behavior Rating Inventory of Executive Function (BRIEF-2) global executive composite standard score over 6 months. 3. Change in autism symptoms measured by Social Responsiveness Scale (SRS-2) total standard score and Repetitive Behaviors Scale (RBS-R) total subscale score over 6 months. 4. Change in adaptive behaviors measured by Vineland Adaptive Behavior Scales (VABS-III) adaptive behavior composite standard score over 6 months. 5. Change in other behaviors measured by Child Behavior Checklist (CBCL) total problems standard score and Short Sensory Profile (SSP) total score over 6 months.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Total
n=21 Participants
Total Participants (RAD001 and Placebo groups)
|
RAD001 - Baseline
n=24 Participants
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
Placebo - 6 Months
n=20 Participants
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast.
|
|---|---|---|---|---|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
WRAML-2 verbal learning core subtest scaled score
|
6.90 score on a scale
Standard Deviation 3.36
|
7.47 score on a scale
Standard Deviation 3.93
|
6.11 score on a scale
Standard Deviation 2.65
|
7.22 score on a scale
Standard Deviation 3.76
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
WRAML-2 verbal learning delayed recall scaled score
|
6.57 score on a scale
Standard Deviation 3.40
|
8.13 score on a scale
Standard Deviation 2.98
|
6.73 score on a scale
Standard Deviation 2.02
|
7.72 score on a scale
Standard Deviation 2.99
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
WRAML-2 verbal learning recognition scaled score
|
5.97 score on a scale
Standard Deviation 3.14
|
6.74 score on a scale
Standard Deviation 3.96
|
5.94 score on a scale
Standard Deviation 3.49
|
6.42 score on a scale
Standard Deviation 4.22
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
BRIEF-2 global executive composite standard score
|
71.18 score on a scale
Standard Deviation 19.35
|
82.61 score on a scale
Standard Deviation 17.43
|
77.68 score on a scale
Standard Deviation 19.77
|
74.24 score on a scale
Standard Deviation 16.97
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
SRS-2 total standard score
|
67.52 score on a scale
Standard Deviation 19.60
|
78.91 score on a scale
Standard Deviation 17.75
|
73.12 score on a scale
Standard Deviation 18.23
|
66.90 score on a scale
Standard Deviation 19.36
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
RBS-R total subscale score
|
23.35 score on a scale
Standard Deviation 19.98
|
14.42 score on a scale
Standard Deviation 5.86
|
16.44 score on a scale
Standard Deviation 16.83
|
19.96 score on a scale
Standard Deviation 16.06
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
VABS-III adaptive behavior composite standard score
|
74.41 score on a scale
Standard Deviation 18.21
|
81.56 score on a scale
Standard Deviation 10.45
|
76.96 score on a scale
Standard Deviation 14.44
|
74.71 score on a scale
Standard Deviation 15.75
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
CBCL total problems standard score
|
80.54 score on a scale
Standard Deviation 18.07
|
90.10 score on a scale
Standard Deviation 13.28
|
85.90 score on a scale
Standard Deviation 13.82
|
81.53 score on a scale
Standard Deviation 14.80
|
|
Change in Memory, Executive Functioning, Autism Symptoms, Adaptive Behaviors, and Other Behaviors at 6 Months
SSP total score
|
128.25 score on a scale
Standard Deviation 26.05
|
143.08 score on a scale
Standard Deviation 16.54
|
137.46 score on a scale
Standard Deviation 21.68
|
126.52 score on a scale
Standard Deviation 28.09
|
Adverse Events
RAD001
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001
n=24 participants at risk
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast.
|
Placebo
n=22 participants at risk
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
4.2%
1/24 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Renal and urinary disorders
Renal lesions
|
4.2%
1/24 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Enterovirus infection
|
4.2%
1/24 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
Other adverse events
| Measure |
RAD001
n=24 participants at risk
RAD001 is formulated as tablets of 5.0 mg or 2.5mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis.
RAD001: RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast.
|
Placebo
n=22 participants at risk
Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10.
Placebo: Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast.
|
|---|---|---|
|
General disorders
Stomatitis
|
12.5%
3/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Psychiatric disorders
Low Tolerance for Frustration
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Nervous system disorders
Seizure
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Ear and labyrinth disorders
Middle Ear Inflammation
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Ear and labyrinth disorders
External Ear Inflammation
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • 6 months
|
9.1%
2/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
0.00%
0/24 • 6 months
|
9.1%
2/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy Nose
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Mucositis Oral
|
29.2%
7/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Oral Pain
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Stomach Pain
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Insect Bite
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Stomatitis
|
16.7%
4/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin Around Mouth
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Inflammatory Cystic Lesions
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Mouth Pain
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Bug Bite Induced Swelling
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cystic Acne
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
Bruising
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
Cholesterol, Triglycerides, HDL, And LD Out Of Range Clinically Significant
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
Easily Bruising
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
LDH Out Of Range Clinically Significant
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
Triglycerides And WBC Out Of Range Clinically Significant
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Blood and lymphatic system disorders
Clinically Significant Out Of Range Labs
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Blood and lymphatic system disorders
Gingival Bleeding
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Blood and lymphatic system disorders
TSH, T4, And WBC Out Of Range, Clinically Significant
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Blood and lymphatic system disorders
WBC, RBC, Hematocrit, And Absolute Neutrophil Out Of Range, Clinically Significant
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Infections and infestations
Upper Respiratory Infection
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Influenza Type A
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Viral Illness
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Flu: Diarrhea, Cough, Running Nose
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
|
Infections and infestations
Otitis Media
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place