Trial Outcomes & Findings for A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) (NCT NCT02781727)
NCT ID: NCT02781727
Last Updated: 2022-01-04
Results Overview
Annualized height velocity (AHV) at 52 weeks for weekly lonapegsomatropin (TransCon hGH) and daily hGH treatment groups
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
162 participants
Primary outcome timeframe
52 weeks
Results posted on
2022-01-04
Participant Flow
Participant milestones
| Measure |
Lonapegsomatropin
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Pre-dosing Period
STARTED
|
106
|
56
|
|
Pre-dosing Period
COMPLETED
|
105
|
56
|
|
Pre-dosing Period
NOT COMPLETED
|
1
|
0
|
|
Treatment Period
STARTED
|
105
|
56
|
|
Treatment Period
COMPLETED
|
104
|
55
|
|
Treatment Period
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Lonapegsomatropin
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Pre-dosing Period
Withdrawal by Subject
|
1
|
0
|
|
Treatment Period
Withdrawal by Subject
|
1
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Baseline characteristics by cohort
| Measure |
Lonapegsomatropin
n=105 Participants
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 Participants
Once daily subcutaneous injection of Genotropin
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.5 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
8.5 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
8.5 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Age, Customized
Age, Categorical · <6 years
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorical · ≥6 years
|
80 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
100 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Height
|
112.93 cm
STANDARD_DEVIATION 14.09 • n=5 Participants
|
112.15 cm
STANDARD_DEVIATION 15.29 • n=7 Participants
|
112.66 cm
STANDARD_DEVIATION 14.48 • n=5 Participants
|
|
Height SDS
|
-2.89 standard deviation score
STANDARD_DEVIATION 0.85 • n=5 Participants
|
-3.00 standard deviation score
STANDARD_DEVIATION 0.90 • n=7 Participants
|
-2.93 standard deviation score
STANDARD_DEVIATION 0.87 • n=5 Participants
|
|
Weight
|
21.01 kg
STANDARD_DEVIATION 6.54 • n=5 Participants
|
21.20 kg
STANDARD_DEVIATION 6.67 • n=7 Participants
|
21.08 kg
STANDARD_DEVIATION 6.56 • n=5 Participants
|
|
Body Mass Index (BMI)
|
16.06 kg/m^2
STANDARD_DEVIATION 1.78 • n=5 Participants
|
16.46 kg/m^2
STANDARD_DEVIATION 2.17 • n=7 Participants
|
16.20 kg/m^2
STANDARD_DEVIATION 1.93 • n=5 Participants
|
|
BMI SDS
|
-0.32 standard deviation score
STANDARD_DEVIATION 0.95 • n=5 Participants
|
-0.14 standard deviation score
STANDARD_DEVIATION 1.07 • n=7 Participants
|
-0.25 standard deviation score
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
IGF-1 SDS
|
-2.08 standard deviation score
STANDARD_DEVIATION 0.88 • n=5 Participants
|
-1.96 standard deviation score
STANDARD_DEVIATION 0.98 • n=7 Participants
|
-2.04 standard deviation score
STANDARD_DEVIATION 0.92 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.
Annualized height velocity (AHV) at 52 weeks for weekly lonapegsomatropin (TransCon hGH) and daily hGH treatment groups
Outcome measures
| Measure |
Lonapegsomatropin
n=105 Participants
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 Participants
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Annualized Height Velocity at 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups
|
11.17 cm/year
Standard Error 0.23
|
10.31 cm/year
Standard Error 0.30
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: The safety analysis population included all randomized subjects who had received at least 1 dose of active treatment.
Number of participants with Treatment-Emergent Adverse Events for the weekly lonapegsomatropin and daily hGH treatment groups
Outcome measures
| Measure |
Lonapegsomatropin
n=105 Participants
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 Participants
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAEs
|
81 Participants
|
39 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAEs related to study drug
|
12 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
SAEs
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
SAEs related to study drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 5, Week 13, Week 26, Week 39 and Week 52Population: The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.
Annualized height velocity (AHV) over 52 weeks for weekly lonapegsomatropin and daily hGH treatment groups. AHV by visit was determined by ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable, treatment and gender as factors, baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.
Outcome measures
| Measure |
Lonapegsomatropin
n=105 Participants
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 Participants
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Annualized Height Velocity Over 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 5
|
13.54 cm/year
Standard Error 1.07
|
12.83 cm/year
Standard Error 1.37
|
|
Annualized Height Velocity Over 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 13
|
13.28 cm/year
Standard Error 0.49
|
12.22 cm/year
Standard Error 0.63
|
|
Annualized Height Velocity Over 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 26
|
12.65 cm/year
Standard Error 0.32
|
11.21 cm/year
Standard Error 0.42
|
|
Annualized Height Velocity Over 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 39
|
11.89 cm/year
Standard Error 0.26
|
10.90 cm/year
Standard Error 0.33
|
|
Annualized Height Velocity Over 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 52
|
11.17 cm/year
Standard Error 0.23
|
10.31 cm/year
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Week 5, Week 13, Week 26, Week 39 and Week 52Population: The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.
Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height SDS was derived using the LMS method as ((Height/M)\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from 2000 CDC growth charts for the United States. A Standard Deviation Score of 0 represents the population mean. A higher change from baseline in Height Standard Deviation Score (SDS) indicates a better outcome. The change from baseline in height SDS by visit was determined by ANCOVA model and included baseline age, peak GH levels (log transformed) at stimulation test and baseline height SDS as covariates, as well as treatment and gender as factors.
Outcome measures
| Measure |
Lonapegsomatropin
n=105 Participants
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 Participants
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Change in Height Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 39
|
0.92 standard deviation score
Standard Error 0.03
|
0.80 standard deviation score
Standard Error 0.04
|
|
Change in Height Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 5
|
0.13 standard deviation score
Standard Error 0.02
|
0.12 standard deviation score
Standard Error 0.02
|
|
Change in Height Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 13
|
0.38 standard deviation score
Standard Error 0.02
|
0.33 standard deviation score
Standard Error 0.03
|
|
Change in Height Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 26
|
0.68 standard deviation score
Standard Error 0.03
|
0.58 standard deviation score
Standard Error 0.04
|
|
Change in Height Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 52
|
1.10 standard deviation score
Standard Error 0.04
|
0.96 standard deviation score
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 13, Week 26, Week 39, and Week 52Population: The Intention-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of active treatment.
IGF-1 Standard Deviation Score (SDS) is the number of standard deviations above or below the mean Insulin-like Growth Factor 1 (IGF-1) level for age and sex. IGF-1 SDS was derived using the LMS method as ((IGF-1/M)\^L)-1)/(L x S), where M = median, S = generalized coefficient of variation, and L = power in the Box-Cox transformation, the M, S, L values were obtained from Bidlingmaier et al. (2014). A Standard Deviation Score of 0 represents the population mean. Average IGF-1 SDS by visit was determined by ANCOVA. The ANCOVA model included baseline age, peak GH levels (log transformed) at stimulation test, baseline IGF-1 SDS as covariates, as well as treatment and gender as factors. Modeled values begin at Week 13 corresponding with achievement of IGF-1 steady state. Average IGF-1 SDS values by visit for the Lonapegsomatropin group were derived from a population pharmacodynamic model; the average IGF-1 SDS values for the Genotropin group are represented by observed values.
Outcome measures
| Measure |
Lonapegsomatropin
n=105 Participants
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 Participants
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Average IGF-1 Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 13
|
0.31 standard deviation score
Standard Error 0.09
|
-0.60 standard deviation score
Standard Error 0.11
|
|
Average IGF-1 Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 26
|
0.46 standard deviation score
Standard Error 0.08
|
-0.51 standard deviation score
Standard Error 0.10
|
|
Average IGF-1 Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 39
|
0.59 standard deviation score
Standard Error 0.09
|
-0.30 standard deviation score
Standard Error 0.11
|
|
Average IGF-1 Standard Deviation Score Over 52 Weeks for the Weekly Lonapegsomatropin and Daily hGH Treatment Groups
Week 52
|
0.72 standard deviation score
Standard Error 0.09
|
-0.02 standard deviation score
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Start of study treatment through Week 52Population: The safety analysis population included all randomized subjects who had received at least 1 dose of active treatment.
Number of participants with treatment emergent anti-hGH binding antibody formation during the 52 week study. All samples were negative for anti-hGH neutralizing antibodies.
Outcome measures
| Measure |
Lonapegsomatropin
n=105 Participants
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 Participants
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Number of Participants With Treatment Emergent Anti-hGH Binding Antibody Formation
|
6 Participants
|
2 Participants
|
Adverse Events
Lonapegsomatropin
Serious events: 1 serious events
Other events: 81 other events
Deaths: 0 deaths
Daily hGH
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lonapegsomatropin
n=105 participants at risk
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 participants at risk
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.95%
1/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
0.00%
0/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
1.8%
1/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
Other adverse events
| Measure |
Lonapegsomatropin
n=105 participants at risk
Once weekly subcutaneous injection of lonapegsomatropin (TransCon hGH)
|
Daily hGH
n=56 participants at risk
Once daily subcutaneous injection of Genotropin
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.4%
12/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
14.3%
8/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Infections and infestations
Pharyngitis
|
9.5%
10/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
17.9%
10/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
6/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
8.9%
5/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
7/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
5.4%
3/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
10/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
7.1%
4/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
9/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
5.4%
3/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
6/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
5.4%
3/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
General disorders
Pyrexia
|
15.2%
16/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
8.9%
5/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Nervous system disorders
Headache
|
12.4%
13/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
12.5%
7/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
|
Endocrine disorders
Secondary hypothyroidism
|
6.7%
7/105 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
|
5.4%
3/56 • From the first trial-related activity after the subject signed the informed consent until the end of the post-treatment follow-up period (up to week 52)
All adverse events (AEs) were collected in response to a general question about the subject's well-being and any possible changes from the previous visit, but were not specifically solicited. AEs, including any serious adverse events, were collected through the end of trial (ie, the Week 52 Visit 6). AEs ongoing at Visit 6 or the time of premature trial discontinuation were followed until the event was resolved or deemed stable by the investigator.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place