Trial Outcomes & Findings for Trial of Growth Hormone Therapy in Pediatric Crohn's Disease (NCT NCT00109473)
NCT ID: NCT00109473
Last Updated: 2020-10-30
Results Overview
The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2020-10-30
Participant Flow
98 subjects were assessed for eligibility, 76 did not meet inclusion criteria, 21 refused to participate
21 subjects enrolled, one withdrew consent prior to randomization.
Participant milestones
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Baseline (0 Through 12 Weeks)
STARTED
|
10
|
10
|
|
Baseline (0 Through 12 Weeks)
Analyzed
|
10
|
10
|
|
Baseline (0 Through 12 Weeks)
COMPLETED
|
10
|
9
|
|
Baseline (0 Through 12 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Week 12 to Week 24
STARTED
|
10
|
9
|
|
Week 12 to Week 24
Analyzed
|
9
|
9
|
|
Week 12 to Week 24
COMPLETED
|
9
|
9
|
|
Week 12 to Week 24
NOT COMPLETED
|
1
|
0
|
|
52 Week Extension Phase
STARTED
|
9
|
8
|
|
52 Week Extension Phase
Analyzed
|
9
|
8
|
|
52 Week Extension Phase
COMPLETED
|
5
|
3
|
|
52 Week Extension Phase
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
Baseline characteristics by cohort
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Age, Continuous
|
12 years
STANDARD_DEVIATION 3 • n=93 Participants
|
13 years
STANDARD_DEVIATION 3 • n=4 Participants
|
13 years
STANDARD_DEVIATION 3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
20 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksThe CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Crohn's Disease Histologic Index of Severity (CDHIS)
Baseline
|
7 scores on a scale
Interval 5.0 to 9.0
|
8 scores on a scale
Interval 6.0 to 10.0
|
|
Crohn's Disease Histologic Index of Severity (CDHIS)
Week 12
|
6 scores on a scale
Interval 4.0 to 8.0
|
8 scores on a scale
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksElevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis. The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean.
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Serum IGF-1 (Insulin-like Growth Factor 1)z Score
Baseline
|
-0.4 Z score
Standard Error 0.6
|
-0.7 Z score
Standard Error 0.3
|
|
Serum IGF-1 (Insulin-like Growth Factor 1)z Score
Week 12
|
1.8 Z score
Standard Error 1
|
-1 Z score
Standard Error 0.3
|
|
Serum IGF-1 (Insulin-like Growth Factor 1)z Score
Week 24
|
3.3 Z score
Standard Error 1.5
|
3.8 Z score
Standard Error 1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksHealth-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life.
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
IMPACT III Score
Baseline
|
134 Scores on a scale
Interval 120.0 to 148.0
|
132 Scores on a scale
Interval 119.0 to 146.0
|
|
IMPACT III Score
Week 12
|
143 Scores on a scale
Interval 129.0 to 157.0
|
136 Scores on a scale
Interval 123.0 to 150.0
|
SECONDARY outcome
Timeframe: Baseline, 12 and 24 weeksThe PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30.
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Pediatric Crohn's Disease Activity Index (PCDAI)
Baseline
|
32 Scores on a scale
Interval 20.0 to 43.0
|
33 Scores on a scale
Interval 25.0 to 40.0
|
|
Pediatric Crohn's Disease Activity Index (PCDAI)
Week 12
|
8 Scores on a scale
Interval 2.0 to 14.0
|
22 Scores on a scale
Interval 14.0 to 30.0
|
|
Pediatric Crohn's Disease Activity Index (PCDAI)
Week 24
|
9 Scores on a scale
Interval 2.0 to 14.0
|
6 Scores on a scale
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: 12 weeksThe total corticosteroid use over 12 weeks between groups, using the unpaired t test.
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=8 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Total Corticosteroid Use
prednisone
|
22 mg
Standard Error 8
|
28 mg
Standard Error 10
|
|
Total Corticosteroid Use
budesonide
|
7 mg
Standard Error 4
|
8 mg
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksMeasure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0-30. A higher score indicates more severe mucosal inflammation.
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Crohn's Disease Endoscopic Index of Severity (CDEIS)
Baseline
|
9 Scores on a scale
Interval -1.0 to 18.0
|
8 Scores on a scale
Interval 2.0 to 13.0
|
|
Crohn's Disease Endoscopic Index of Severity (CDEIS)
Week 12
|
3 Scores on a scale
Interval 1.0 to 6.0
|
6 Scores on a scale
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: Baseline, week 12, 24 and 48Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height. It is calculated by measuring height at two points of time and then dividing the change by the amount of time.
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Height Velocity
Baseline
|
5 cm/year
Standard Error 1
|
3 cm/year
Standard Error 1
|
|
Height Velocity
Week 12
|
8 cm/year
Standard Error 1
|
3 cm/year
Standard Error 1
|
|
Height Velocity
Week 24
|
9 cm/year
Standard Error 1
|
7 cm/year
Standard Error 1
|
SECONDARY outcome
Timeframe: At 24 and 64 weeksFecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease.
Outcome measures
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 Participants
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 Participants
Subjects took corticosteroid as prescribed by their physician
|
|---|---|---|
|
Fecal Calprotectin
Baseline
|
863 micrograms per gram (microg/g)
Interval 517.0 to 1209.0
|
904 micrograms per gram (microg/g)
Interval 540.0 to 1269.0
|
|
Fecal Calprotectin
Week 12
|
868 micrograms per gram (microg/g)
Interval 523.0 to 1214.0
|
656 micrograms per gram (microg/g)
Interval 310.0 to 1002.0
|
Adverse Events
Growth Hormone Plus Corticosteroid (CTX)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Corticosteroid (CTX)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Extension Phase
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 participants at risk
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 participants at risk
Subjects took corticosteroid as recommended by their physician
|
Extension Phase
n=17 participants at risk
Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Bruising at injection site
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
General disorders
Abdominal Pain
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Pancreatitis
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
Growth Hormone Plus Corticosteroid (CTX)
n=10 participants at risk
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
|
Corticosteroid (CTX)
n=10 participants at risk
Subjects took corticosteroid as recommended by their physician
|
Extension Phase
n=17 participants at risk
Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
|
|---|---|---|---|
|
Immune system disorders
Allergic Rhinitis
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
17.6%
3/17 • Number of events 3
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Immune system disorders
Lactose intolerant
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
ANC elevated
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Basophils elevated
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased hematocrit
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Eosinophils elevated
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
17.6%
3/17 • Number of events 3
|
|
Blood and lymphatic system disorders
Ferritin decrease
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematocrit decreased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematocrit elevated
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
20.0%
2/10 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron level decreased
|
0.00%
0/10
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Iron level elevated
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
30.0%
3/10 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Lymphocytes elevated
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Monocytes elevated
|
20.0%
2/10 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
17.6%
3/17 • Number of events 4
|
|
Blood and lymphatic system disorders
RBC decreased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Blood and lymphatic system disorders
RBC elevated
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
RDW elevated
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Sedimentation Rate Elevated
|
0.00%
0/10
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Segs elevated
|
0.00%
0/10
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Fatigue
|
10.0%
1/10 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
17.6%
3/17 • Number of events 3
|
|
General disorders
Fever
|
20.0%
2/10 • Number of events 3
|
20.0%
2/10 • Number of events 2
|
47.1%
8/17 • Number of events 8
|
|
General disorders
Increased thirst
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Insomnia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Weight loss
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
17.6%
3/17 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Bruising at injection site
|
40.0%
4/10 • Number of events 5
|
20.0%
2/10 • Number of events 2
|
29.4%
5/17 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Insect bite
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
2/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/10
|
0.00%
0/10
|
17.6%
3/17 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Seborrhea
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cushingoid
|
60.0%
6/10 • Number of events 6
|
20.0%
2/10 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
17.6%
3/17 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
58.8%
10/17 • Number of events 11
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Fecal urgency
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
hemorrhoids
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
29.4%
5/17 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
35.3%
6/17 • Number of events 8
|
|
Gastrointestinal disorders
Hemorrhage nasal
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
0.00%
0/17
|
|
Infections and infestations
Colitis, infectious
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Gastric infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
17.6%
3/17 • Number of events 5
|
|
Infections and infestations
Oral thrush infection
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Skin Infection
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
ALT decreased
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
ALT increased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
17.6%
3/17 • Number of events 3
|
|
Metabolism and nutrition disorders
AST increased
|
0.00%
0/10
|
0.00%
0/10
|
41.2%
7/17 • Number of events 9
|
|
Metabolism and nutrition disorders
Alkaline phosphate decreased
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Anion gap high
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Anti-mitochondrial antibody
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
BUN
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
BUN decreased
|
40.0%
4/10 • Number of events 5
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
BUN elevated
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Blood bicarbonate elevated
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
29.4%
5/17 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood glucose decreased
|
30.0%
3/10 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/10
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
CRP elevated
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Chloride elevated
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatnine decreased
|
40.0%
4/10 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
17.6%
3/17 • Number of events 3
|
|
Metabolism and nutrition disorders
Creatinine elevated
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyperinsulinemia
|
0.00%
0/10
|
0.00%
0/10
|
29.4%
5/17 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
30.0%
3/10 • Number of events 3
|
30.0%
3/10 • Number of events 3
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/10
|
0.00%
0/10
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Urine calcium decreased
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Anxiety
|
10.0%
1/10 • Number of events 2
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Concussion
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Depression
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
General disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
41.2%
7/17 • Number of events 7
|
|
General disorders
Back pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
General disorders
Breast pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 1
|
40.0%
4/10 • Number of events 4
|
17.6%
3/17 • Number of events 3
|
|
General disorders
Joint Pain
|
60.0%
6/10 • Number of events 6
|
10.0%
1/10 • Number of events 1
|
17.6%
3/17 • Number of events 3
|
|
General disorders
Myalgia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Pain in extremity
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Pharyngolaryngeal pain
|
10.0%
1/10 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Rectal pain
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Shoulder
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/17
|
|
General disorders
Cough
|
20.0%
2/10 • Number of events 2
|
40.0%
4/10 • Number of events 4
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Sinus congestion
|
0.00%
0/10
|
10.0%
1/10 • Number of events 3
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Dysuria
|
0.00%
0/10
|
0.00%
0/10
|
5.9%
1/17 • Number of events 1
|
Additional Information
Lee A. Denson
Cincinnati Children's Hospital Medical Center
Phone: 513-636-7575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place