Trial Outcomes & Findings for A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency (NCT NCT04615273)
NCT ID: NCT04615273
Last Updated: 2025-01-15
Results Overview
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
264 participants
Primary outcome timeframe
Baseline, Week 38
Results posted on
2025-01-15
Participant Flow
Participant milestones
| Measure |
Lonapegsomatropin
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
87
|
87
|
|
Overall Study
Treated
|
89
|
84
|
86
|
|
Overall Study
COMPLETED
|
85
|
81
|
82
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
5
|
Reasons for withdrawal
| Measure |
Lonapegsomatropin
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
|
Overall Study
Randomized but not treated
|
1
|
3
|
1
|
Baseline Characteristics
A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
Baseline characteristics by cohort
| Measure |
Lonapegsomatropin
n=89 Participants
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
n=84 Participants
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
n=86 Participants
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 13.40 • n=99 Participants
|
44.1 years
STANDARD_DEVIATION 14.74 • n=107 Participants
|
41.3 years
STANDARD_DEVIATION 14.34 • n=206 Participants
|
42.8 years
STANDARD_DEVIATION 14.15 • n=7 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
119 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
140 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
239 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
72 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
218 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Dose Group
Subgroup 1: Oral estrogen intake or <30 years old
|
32 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
91 Participants
n=7 Participants
|
|
Dose Group
Subgroup 2: >=30 to <=60 years old; no oral estrogen intake
|
46 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
134 Participants
n=7 Participants
|
|
Dose Group
Subgroup 3: >60 years old; no oral estrogen intake
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 38Population: Analysis was performed on Intent-To-Treat population that consisted of all randomized participants who received any amount of the trial drug and were analyzed by the treatment arm as randomized. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for lonapegsomatropin and placebo groups, and not for somatropin group.
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Lonapegsomatropin
n=82 Participants
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
n=77 Participants
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
Change From Baseline in Trunk Percent Fat at Week 38
|
-1.68 percent fat
Interval -2.44 to -0.91
|
0.37 percent fat
Interval -0.3 to 1.03
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 38Population: Analysis was performed on Intent-to-Treat population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for lonapegsomatropin and placebo groups, and not for somatropin group.
Total body lean mass was assessed by dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Lonapegsomatropin
n=82 Participants
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
n=77 Participants
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Body Lean Mass at Week 38
|
1.60 kilograms
Interval 1.0 to 2.19
|
-0.11 kilograms
Interval -0.72 to 0.51
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 38Population: Analysis was performed on Intent-to-Treat population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for lonapegsomatropin and placebo groups, and not for somatropin group.
Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Lonapegsomatropin
n=82 Participants
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
n=77 Participants
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
Change From Baseline in Trunk Fat Mass at Week 38
|
-0.48 kilograms
Interval -0.89 to -0.07
|
0.22 kilograms
Interval -0.15 to 0.6
|
—
|
SECONDARY outcome
Timeframe: Up to 38 weeksPopulation: Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE was considered a TEAE if it occurred on or after the first dose of investigational product and was not present prior to the first dose, or it was present at the first dose but increased in severity during the trial. A serious AE is any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator.
Outcome measures
| Measure |
Lonapegsomatropin
n=89 Participants
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
n=84 Participants
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
n=86 Participants
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
TEAEs
|
64 Participants
|
55 Participants
|
63 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
Serious TEAEs
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
TEAE Leading to Study Discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Lonapegsomatropin
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Somatropin
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lonapegsomatropin
n=89 participants at risk
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
n=84 participants at risk
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
n=86 participants at risk
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/89 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/86 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
General disorders
Face oedema
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/86 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/86 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Nervous system disorders
Epilepsy
|
1.1%
1/89 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/86 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/86 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Infections and infestations
Coronavirus pneumonia
|
1.1%
1/89 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/86 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/89 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/86 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/84 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/86 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/86 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/86 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/86 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/89 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
0.00%
0/84 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
1.2%
1/86 • Number of events 1 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
Other adverse events
| Measure |
Lonapegsomatropin
n=89 participants at risk
Participants received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Placebo
n=84 participants at risk
Participants received placebo matched to lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 38 weeks.
|
Somatropin
n=86 participants at risk
Participants received somatropin administered once daily by subcutaneous injection for a treatment period of up to 38 weeks.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
7.9%
7/89 • Number of events 7 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
13.1%
11/84 • Number of events 11 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
7.0%
6/86 • Number of events 7 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
8/89 • Number of events 8 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
9.5%
8/84 • Number of events 8 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
8.1%
7/86 • Number of events 9 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
5/89 • Number of events 6 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
13.1%
11/84 • Number of events 16 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
7.0%
6/86 • Number of events 7 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Nervous system disorders
Headache
|
7.9%
7/89 • Number of events 13 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
10.7%
9/84 • Number of events 11 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
5.8%
5/86 • Number of events 5 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
2/89 • Number of events 2 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
9.5%
8/84 • Number of events 10 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
4.7%
4/86 • Number of events 5 • From signing of the informed consent form (ICF) up to 2 weeks after last dose of the study treatment (i.e., up to Week 40)
Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place