Trial Outcomes & Findings for Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency (NCT NCT00125164)
NCT ID: NCT00125164
Last Updated: 2019-09-18
Results Overview
Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
Measured at baseline and at one year
Results posted on
2019-09-18
Participant Flow
Study Initiation Date: 14 March 2004. Study completion Date: 02 July 2008. 44 investigators screened subjects; 14 did not enroll any subjects. 137 subjects were enrolled. Consent for one randomized subject was withdrawn prior to any study measurements. This subject was excluded from all analyses.
Subject screening consisted of three staged clinic visits over 6 weeks, including a medical history, complete physical examination, IGF-1 measurements, a Growth Hormone (GH) stimulation test, and an IGF-1 generation test.
Participant milestones
| Measure |
Untreated
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
16
|
44
|
51
|
|
Overall Study
COMPLETED
|
23
|
16
|
40
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
4
|
6
|
Reasons for withdrawal
| Measure |
Untreated
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
1
|
Baseline Characteristics
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Baseline characteristics by cohort
| Measure |
Untreated
n=25 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
n=16 Participants
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=44 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=51 Participants
Injection of rhIGF-1 120 μg/kg BID
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
7.0 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
7.6 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
7.7 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
7.6 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
7.5 years
STANDARD_DEVIATION 2.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
22 participants
n=5 Participants
|
16 participants
n=7 Participants
|
38 participants
n=5 Participants
|
41 participants
n=4 Participants
|
117 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Stratum
Height Standard Deviation Score < -2.6
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
25 participants
n=5 Participants
|
30 participants
n=4 Participants
|
76 participants
n=21 Participants
|
|
Stratum
Height Standard Deviation Score >= -2.6
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
21 participants
n=4 Participants
|
60 participants
n=21 Participants
|
|
Height Standard Deviation (SD) Score
|
-2.8 SD
STANDARD_DEVIATION 0.7 • n=5 Participants
|
-2.6 SD
STANDARD_DEVIATION 0.6 • n=7 Participants
|
-2.7 SD
STANDARD_DEVIATION 0.5 • n=5 Participants
|
-2.9 SD
STANDARD_DEVIATION 0.8 • n=4 Participants
|
-2.8 SD
STANDARD_DEVIATION 0.7 • n=21 Participants
|
|
IGF-1 Standard Deviation (SD) Score
|
-2.6 SD
STANDARD_DEVIATION 0.7 • n=5 Participants
|
-2.8 SD
STANDARD_DEVIATION 0.8 • n=7 Participants
|
-2.6 SD
STANDARD_DEVIATION 0.7 • n=5 Participants
|
-3.0 SD
STANDARD_DEVIATION 0.8 • n=4 Participants
|
-2.8 SD
STANDARD_DEVIATION 0.8 • n=21 Participants
|
|
Maximum Stimulated Growth Hormone
|
17.0 ng/mL
STANDARD_DEVIATION 6.5 • n=5 Participants
|
16.9 ng/mL
STANDARD_DEVIATION 6.2 • n=7 Participants
|
17.8 ng/mL
STANDARD_DEVIATION 9.0 • n=5 Participants
|
20.7 ng/mL
STANDARD_DEVIATION 16.8 • n=4 Participants
|
18.6 ng/mL
STANDARD_DEVIATION 12.1 • n=21 Participants
|
|
Weight
|
17.8 Kg
STANDARD_DEVIATION 4.6 • n=5 Participants
|
18.5 Kg
STANDARD_DEVIATION 4.7 • n=7 Participants
|
19.4 Kg
STANDARD_DEVIATION 5.4 • n=5 Participants
|
18.5 Kg
STANDARD_DEVIATION 5.7 • n=4 Participants
|
18.6 Kg
STANDARD_DEVIATION 5.3 • n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and at one yearPopulation: A modified intention-to-treat population consisting of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
Outcome measures
| Measure |
Untreated
n=22 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=42 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=49 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Height Velocity During the First Year - Intent to Treat (ITT)Population
|
5.2 cm/yr
Standard Deviation 1.0
|
—
|
6.9 cm/yr
Standard Deviation 1.0
|
7.7 cm/yr
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Measured at baseline and at one yearPopulation: A modified intention-to-treat population that consists of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.
Outcome measures
| Measure |
Untreated
n=22 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=42 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=49 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population
|
0.02 SD/year
Standard Deviation 0.24
|
—
|
0.38 SD/year
Standard Deviation 0.17
|
0.48 SD/year
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Measured at baseline and at one yearPopulation: All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.
Outcome measures
| Measure |
Untreated
n=23 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=40 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=44 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Changes in Bone Age From Baseline to One Year
|
0.8 Year
Standard Deviation 0.3
|
—
|
1.1 Year
Standard Deviation 0.4
|
1.2 Year
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Measured at baseline and at one yearPopulation: All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel.
Outcome measures
| Measure |
Untreated
n=18 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=34 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=42 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year
|
64 Percent change
Standard Deviation 120
|
—
|
227 Percent change
Standard Deviation 220
|
266 Percent change
Standard Deviation 215
|
SECONDARY outcome
Timeframe: Measured at baseline and at one yearPopulation: All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Blood sample was collected for measuring the level of IGF-2 in the growth factor panel.
Outcome measures
| Measure |
Untreated
n=17 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=35 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=40 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year
|
14 Percent change
Standard Deviation 28
|
—
|
-38 Percent change
Standard Deviation 37
|
-37 Percent change
Standard Deviation 32
|
SECONDARY outcome
Timeframe: Measured at baseline and at one yearPopulation: All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel.
Outcome measures
| Measure |
Untreated
n=15 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=32 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=34 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year
|
-16 Percent change
Standard Deviation 26
|
—
|
58 Percent change
Standard Deviation 84
|
61 Percent change
Standard Deviation 79
|
SECONDARY outcome
Timeframe: Measured at baseline and at one yearPopulation: All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.
Outcome measures
| Measure |
Untreated
n=18 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=34 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=42 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year
|
13 Percent change
Standard Deviation 33
|
—
|
-19 Percent change
Standard Deviation 22
|
-19 Percent change
Standard Deviation 28
|
SECONDARY outcome
Timeframe: Study Day 1 and Day 7Population: All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.
Outcome measures
| Measure |
Untreated
n=18 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=34 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=42 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)
|
40 ng/mL
Standard Deviation 49
|
—
|
53 ng/mL
Standard Deviation 49
|
48 ng/mL
Standard Deviation 43
|
SECONDARY outcome
Timeframe: Study Day 1 and Day 7Population: All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.
Outcome measures
| Measure |
Untreated
n=18 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=34 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=42 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)
|
744 mg/dL
Standard Deviation 459
|
—
|
800 mg/dL
Standard Deviation 1095
|
681 mg/dL
Standard Deviation 568
|
POST_HOC outcome
Timeframe: One YearPopulation: All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
Outcome measures
| Measure |
Untreated
n=21 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=39 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=43 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Height Velocity During the First Year for Subjects - Completers
|
5.2 cm/year
Standard Deviation 1.0
|
—
|
7.0 cm/year
Standard Deviation 1.0
|
7.9 cm/year
Standard Deviation 1.4
|
POST_HOC outcome
Timeframe: One YearPopulation: All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.
Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.
Outcome measures
| Measure |
Untreated
n=21 Participants
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=39 Participants
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=43 Participants
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Change From Baseline in Height Standard Deviation (SD) Score at One Year - Completers
|
0.02 SD/year
Standard Deviation 0.24
|
—
|
0.39 SD/year
Standard Deviation 0.17
|
0.53 SD/year
Standard Deviation 0.30
|
Adverse Events
Untreated
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
40 μg/kg BID (Twice Daily Dosing)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
80 μg/kg BID (Twice Daily Dosing)
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
120 μg/kg BID (Twice Daily Dosing)
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Untreated
n=25 participants at risk
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
n=16 participants at risk
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=44 participants at risk
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=51 participants at risk
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Congenital, familial and genetic disorders
Cor Triatriatum
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Endocrine disorders
Hypoglycemic seizure
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/51 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Gastrointestinal disorders
Gastroenteritis escherichia coli
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/51 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/51 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/51 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Nervous system disorders
Benign Itracranial Hypertension
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/44 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.0%
1/51 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/51 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
Other adverse events
| Measure |
Untreated
n=25 participants at risk
Observational Group
|
40 μg/kg BID (Twice Daily Dosing)
n=16 participants at risk
Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
|
80 μg/kg BID (Twice Daily Dosing)
n=44 participants at risk
Injection of rhIGF-1 80 μg/kg BID
|
120 μg/kg BID (Twice Daily Dosing)
n=51 participants at risk
Injection of rhIGF-1 120 μg/kg BID
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.0%
4/25 • Number of events 9 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
50.0%
8/16 • Number of events 16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
29.5%
13/44 • Number of events 30 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
41.2%
21/51 • Number of events 35 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
24.0%
6/25 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
18.8%
3/16 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
22.7%
10/44 • Number of events 17 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
23.5%
12/51 • Number of events 13 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
4/25 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
25.0%
4/16 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
22.7%
10/44 • Number of events 17 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
13.7%
7/51 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
12.5%
2/16 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
11.4%
5/44 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
13.7%
7/51 • Number of events 12 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
1/25 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
12.5%
2/16 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.8%
3/44 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
17.6%
9/51 • Number of events 10 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
18.8%
3/16 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
18.2%
8/44 • Number of events 10 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
5.9%
3/51 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Pharyngitis streptococcal
|
8.0%
2/25 • Number of events 2 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
9.1%
4/44 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
13.7%
7/51 • Number of events 9 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
25.0%
4/16 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
11.4%
5/44 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
9.8%
5/51 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
General disorders
Injection site bruising
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
18.8%
3/16 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
13.6%
6/44 • Number of events 10 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
7.8%
4/51 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
General disorders
Injection site pain
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
12.5%
2/16 • Number of events 2 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
15.9%
7/44 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
7.8%
4/51 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Influenza
|
4.0%
1/25 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
9.1%
4/44 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
13.7%
7/51 • Number of events 10 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
25.0%
4/16 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
13.6%
6/44 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
3.9%
2/51 • Number of events 2 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Otitis media
|
12.0%
3/25 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
18.8%
3/16 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
4.5%
2/44 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
7.8%
4/51 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.8%
3/44 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
11.8%
6/51 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
18.8%
3/16 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
9.1%
4/44 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
7.8%
4/51 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
18.8%
3/16 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
9.1%
4/44 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
5.9%
3/51 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/25 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.2%
1/16 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
11.8%
6/51 • Number of events 8 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Infections and infestations
Sinusitis
|
12.0%
3/25 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
0.00%
0/16 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
7.8%
4/51 • Number of events 8 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
|
Ear and labyrinth disorders
Ear pain
|
8.0%
2/25 • Number of events 2 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
6.8%
3/44 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
2.0%
1/51 • Number of events 2 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was 1 year 1 month. Across study adverse event reporting continued for a total of 4 years 5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Each investigator may publish or report data from their own subjects. The trial data in aggregate are the property of Tercica, Inc. and may not be published without permission of Tercica, Inc. Tercica, Inc. will be the final arbitrator of issues relating to the publication or presentation of the aggregate data.
- Publication restrictions are in place
Restriction type: OTHER