Trial Outcomes & Findings for Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency (NCT NCT00109733)
NCT ID: NCT00109733
Last Updated: 2013-08-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2013-08-07
Participant Flow
Study Initiation Date: 06 Jan 2005 (date of first subject, first dose) Study Completion Date 11 Jun 2006 (date of last subject, last visit) 19 study centres in the United States received IRB approval to participate in this study; 13 of the centres enrolled at least one subject into the study.
All study screening assessments were to be performed within a 30-day period prior to study entry. A total of 40 subjects were screened for the study and 31 of them (77.5%) were randomised and received study drug.
Participant milestones
| Measure |
Standard Dose Group
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Standard Dose Group
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Stopped taking study drug
|
1
|
1
|
|
Overall Study
Non-compliant
|
0
|
1
|
|
Overall Study
Could not commit time for study
|
1
|
1
|
Baseline Characteristics
Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency
Baseline characteristics by cohort
| Measure |
Standard Dose Group
n=15 Participants
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=16 Participants
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
17.4 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
18.1 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
17.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Lean body mass
|
44.03 kg
STANDARD_DEVIATION 11.09 • n=5 Participants
|
44.38 kg
STANDARD_DEVIATION 12.98 • n=7 Participants
|
44.21 kg
STANDARD_DEVIATION 11.90 • n=5 Participants
|
|
Limb fat
|
11.47 kg
STANDARD_DEVIATION 5.49 • n=5 Participants
|
12.92 kg
STANDARD_DEVIATION 9.28 • n=7 Participants
|
12.22 kg
STANDARD_DEVIATION 7.59 • n=5 Participants
|
|
Total body fat
|
24.02 kg
STANDARD_DEVIATION 10.81 • n=5 Participants
|
25.11 kg
STANDARD_DEVIATION 18.29 • n=7 Participants
|
24.58 kg
STANDARD_DEVIATION 14.90 • n=5 Participants
|
|
Trunk fat
|
11.73 kg
STANDARD_DEVIATION 5.58 • n=5 Participants
|
11.40 kg
STANDARD_DEVIATION 9.09 • n=7 Participants
|
11.56 kg
STANDARD_DEVIATION 7.47 • n=5 Participants
|
|
Trunk to limb fat ratio
|
1.05 ratio
STANDARD_DEVIATION 0.29 • n=5 Participants
|
0.87 ratio
STANDARD_DEVIATION 0.17 • n=7 Participants
|
0.96 ratio
STANDARD_DEVIATION 0.25 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Intention To Treat, Last Observation Carried Forward
Outcome measures
| Measure |
Standard Dose Group
n=13 Participants
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=15 Participants
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Trunk Fat
|
-6.27 percent change
Standard Deviation 12.72
|
-8.36 percent change
Standard Deviation 17.69
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intention To Treat, Last Observation Carried Forward
Outcome measures
| Measure |
Standard Dose Group
n=13 Participants
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=15 Participants
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Lean Body Mass
|
3.85 percent change
Standard Deviation 4.05
|
7.10 percent change
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intention To Treat, Last Observation Carried Forward
Outcome measures
| Measure |
Standard Dose Group
n=13 Participants
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=15 Participants
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Total Body Fat
|
-4.62 percent change
Standard Deviation 9.96
|
-9.69 percent change
Standard Deviation 10.54
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intention To Treat, Last Observation Carried Forward
Outcome measures
| Measure |
Standard Dose Group
n=13 Participants
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=15 Participants
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Limb Fat
|
-3.77 percent change
Standard Deviation 8.85
|
-11.09 percent change
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intention To Treat, Last Observation Carried Forward
Outcome measures
| Measure |
Standard Dose Group
n=13 Participants
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=15 Participants
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio
|
-2.86 percent change
Standard Deviation 6.77
|
2.92 percent change
Standard Deviation 16.16
|
Adverse Events
Standard Dose Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
High Dose Group
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Dose Group
n=15 participants at risk
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=16 participants at risk
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
Other adverse events
| Measure |
Standard Dose Group
n=15 participants at risk
0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
|
High Dose Group
n=16 participants at risk
0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 2 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 2 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • Number of events 3 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
12.5%
2/16 • Number of events 3 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Dental caries
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Endocrine disorders
Diabetes insipidus
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
12.5%
2/16 • Number of events 2 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
13.3%
2/15 • Number of events 3 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 2 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Nervous system disorders
Headache
|
40.0%
6/15 • Number of events 9 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
37.5%
6/16 • Number of events 11 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
General disorders
Injection site bruising
|
13.3%
2/15 • Number of events 2 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
General disorders
Injection site haemorrhage
|
6.7%
1/15 • Number of events 2 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Investigations
Insulin-like growth factor increased
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
18.8%
3/16 • Number of events 4 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 2 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Otitis media
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
18.8%
3/16 • Number of events 3 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Nervous system disorders
Tension headache
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
26.7%
4/15 • Number of events 4 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
18.8%
3/16 • Number of events 4 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/15 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
|
Infections and infestations
Wound infection
|
6.7%
1/15 • Number of events 1 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
0.00%
0/16 • Baseline to Week 28(+/-5 days)
AEs are any untoward medical occurrence in the form of signs, symptoms, abnormal labs or diseases that emerged or worsened relative to baseline (present at the initial study visit) regardless of causal relationship, even if no investigational product was administered. The only SAE occurred approximately 1 month prior to start of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60