Trial Outcomes & Findings for Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients (NCT NCT00082628)
NCT ID: NCT00082628
Last Updated: 2018-07-20
Results Overview
Absolute area of VAT was measured by cross-sectional computed tomography (CT) scan at the level of the L4-5 inter-vertebral disk. CT scanning was to be used to assess the cross sectional area of abdominal fat and its distribution between the visceral and subcutaneous compartments, as measured at L4-L5.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
326 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Period I: Placebo
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
Period II: Serostim® 4 mg to Placebo
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II.
|
Period II: Serostim® 4 mg to Serostim® 2 mg
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II.
|
Period II: Placebo to Placebo/Serostim® 4 mg
All subjects who were initially randomized to Placebo arm in Period I continued receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.
|
|---|---|---|---|---|---|
|
Treatment Period I (Week 1 to Week 12)
STARTED
|
81
|
245
|
0
|
0
|
0
|
|
Treatment Period I (Week 1 to Week 12)
COMPLETED
|
73
|
185
|
0
|
0
|
0
|
|
Treatment Period I (Week 1 to Week 12)
NOT COMPLETED
|
8
|
60
|
0
|
0
|
0
|
|
Treatment Period II: Week 12 to Week 36
STARTED
|
0
|
0
|
93
|
92
|
73
|
|
Treatment Period II: Week 12 to Week 36
COMPLETED
|
0
|
0
|
78
|
76
|
55
|
|
Treatment Period II: Week 12 to Week 36
NOT COMPLETED
|
0
|
0
|
15
|
16
|
18
|
Reasons for withdrawal
| Measure |
Period I: Placebo
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
Period II: Serostim® 4 mg to Placebo
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II.
|
Period II: Serostim® 4 mg to Serostim® 2 mg
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II.
|
Period II: Placebo to Placebo/Serostim® 4 mg
All subjects who were initially randomized to Placebo arm in Period I continued receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.
|
|---|---|---|---|---|---|
|
Treatment Period I (Week 1 to Week 12)
Subjects Did Not Receive Study Drug
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period I (Week 1 to Week 12)
Subjects Without Post-Baseline Assessmen
|
2
|
1
|
0
|
0
|
0
|
|
Treatment Period I (Week 1 to Week 12)
Subjects Did Not Complete Week 12
|
5
|
43
|
0
|
0
|
0
|
|
Treatment Period I (Week 1 to Week 12)
Did not continue to Period II
|
1
|
15
|
0
|
0
|
0
|
|
Treatment Period II: Week 12 to Week 36
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period II: Week 12 to Week 36
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period II: Week 12 to Week 36
Subjects Did Not Complete Week 36
|
0
|
0
|
15
|
15
|
17
|
Baseline Characteristics
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
Baseline characteristics by cohort
| Measure |
Period I: Placebo
n=79 Participants
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
n=243 Participants
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
44.5 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
44.8 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Absolute area of VAT was measured by cross-sectional computed tomography (CT) scan at the level of the L4-5 inter-vertebral disk. CT scanning was to be used to assess the cross sectional area of abdominal fat and its distribution between the visceral and subcutaneous compartments, as measured at L4-L5.
Outcome measures
| Measure |
Period I: Placebo
n=74 Participants
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
n=210 Participants
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
|---|---|---|
|
Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12
|
0.5 Square Centimeter (cm^2)
Standard Deviation 34.5
|
-32.6 Square Centimeter (cm^2)
Standard Deviation 37.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Changes in trunk fat was measured as changes in mass (kg) on Dual-Energy X-Ray Absorptiometry (DXA) Scan.
Outcome measures
| Measure |
Period I: Placebo
n=75 Participants
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
n=213 Participants
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
|---|---|---|
|
Treatment Period I: Change From Baseline in Trunk Fat at Week 12
|
0.2 Kilogram (Kg)
Standard Deviation 1.3
|
-2.2 Kilogram (Kg)
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I.
Body image distress was assessed on a scale ranging from 0 to 100, where 0 = Extremely Upsetting and 100 = Extremely Encouraging.
Outcome measures
| Measure |
Period I: Placebo
n=79 Participants
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
n=243 Participants
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
|---|---|---|
|
Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12
|
0.23 units on a scale
Standard Deviation 1.42
|
0.10 units on a scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Lipid profile data was analyzed for Non-HDL Cholesterol.
Outcome measures
| Measure |
Period I: Placebo
n=74 Participants
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
n=226 Participants
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
|---|---|---|
|
Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12
|
-2.8 milligram/deciliter (mg/dL)
Standard Deviation 28.1
|
-13.0 milligram/deciliter (mg/dL)
Standard Deviation 37.1
|
SECONDARY outcome
Timeframe: Week 36Population: The modified ITT Population for treatment period II was defined as subjects who were re-randomized into Weeks 12 to 36 of the study and who had at least one post-Week 12 efficacy evaluation. Here "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
Failure rate based on VAT was assessed by CT scan at L4-L5. The failure rate was defined as the percentage of subjects who regained \>50% of their VAT lost in Treatment Period I. This outcome was to be assessed for subjects who received Serostim® 4 mg in Period I.
Outcome measures
| Measure |
Period I: Placebo
n=83 Participants
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg
n=75 Participants
Subjects received Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
|---|---|---|
|
Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I
|
53.7 percentage of subjects
|
40.3 percentage of subjects
|
Adverse Events
Period I: Placebo (Week 1 to 12)
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
Period I: Serostim® 4 mg (Week 1 to 12)
Serious events: 3 serious events
Other events: 244 other events
Deaths: 0 deaths
Period II: Serostim® 4 mg to Placebo (Week 12 to 36)
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36)
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Period II: Placebo to Placebo (Week 12 to Week 24)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Period II: Placebo to Serostim® 4 mg (Week 24 to 36)
Serious events: 1 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period I: Placebo (Week 1 to 12)
n=81 participants at risk
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg (Week 1 to 12)
n=244 participants at risk
Subjects received serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
Period II: Serostim® 4 mg to Placebo (Week 12 to 36)
n=93 participants at risk
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II.
|
Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36)
n=92 participants at risk
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II.
|
Period II: Placebo to Placebo (Week 12 to Week 24)
n=73 participants at risk
All subjects who were initially randomized to Placebo arm in Period I continued receiving placebo matched to Serostim® on alternate days for 12 weeks in Period II.
|
Period II: Placebo to Serostim® 4 mg (Week 24 to 36)
n=73 participants at risk
All subjects who were initially randomized to Placebo arm in Period I and received Serostim® 4 mg daily 12 weeks in Period II.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
1.2%
1/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Investigations
Liver function test abnormal
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.41%
1/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.41%
1/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Nervous system disorders
Migraine
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.41%
1/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.41%
1/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Infections and infestations
Diarrhoea
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Infections and infestations
Pancreatic insufficiency
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Infections and infestations
Groin abscess
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
Other adverse events
| Measure |
Period I: Placebo (Week 1 to 12)
n=81 participants at risk
Subjects received placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
|
Period I: Serostim® 4 mg (Week 1 to 12)
n=244 participants at risk
Subjects received serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
|
Period II: Serostim® 4 mg to Placebo (Week 12 to 36)
n=93 participants at risk
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received placebo matched to Serostim® on alternate days for 24 weeks in Period II.
|
Period II: Serostim® 4 mg to Serostim® 2 mg (Week 12 to 36)
n=92 participants at risk
All subjects who were initially randomized to Serostim® 4 mg arm in Period I and received Serostim® 2 mg on alternate days for 24 weeks in Period II.
|
Period II: Placebo to Placebo (Week 12 to Week 24)
n=73 participants at risk
All subjects who were initially randomized to Placebo arm in Period I continued receiving placebo matched to Serostim® on alternate days for 12 weeks in Period II.
|
Period II: Placebo to Serostim® 4 mg (Week 24 to 36)
n=73 participants at risk
All subjects who were initially randomized to Placebo arm in Period I and received Serostim® 4 mg daily 12 weeks in Period II.
|
|---|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
4.9%
4/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
46.3%
113/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
4.3%
4/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
6.5%
6/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
46.6%
34/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Arthralgia
|
17.3%
14/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
38.9%
95/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.4%
5/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
8.7%
8/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.7%
2/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
41.1%
30/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Pain in extremity
|
3.7%
3/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
18.9%
46/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.4%
5/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.2%
2/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.7%
2/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
26.0%
19/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Headache
|
3.7%
3/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
16.0%
39/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
4.3%
4/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.4%
5/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
11.0%
8/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Myalgia
|
3.7%
3/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
13.9%
34/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
19.2%
14/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Blood glucose increased
|
2.5%
2/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
13.5%
33/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
3.2%
3/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
6.5%
6/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.7%
2/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
15.1%
11/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Hypoaesthesia
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
13.9%
34/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.4%
5/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
11.0%
8/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Paraesthesia
|
3.7%
3/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
10.2%
25/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
6.8%
5/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Fatigue
|
1.2%
1/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
9.4%
23/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
8.2%
6/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Insomnia
|
2.5%
2/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
9.0%
22/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Joint stiffness
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
9.0%
22/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.5%
4/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Back pain
|
4.9%
4/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
6.1%
15/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
4.1%
3/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Musculoskeletal stiffness
|
1.2%
1/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
7.4%
18/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
12.3%
9/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Upper respiratory tract infection
|
7.4%
6/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.3%
13/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
16.1%
15/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
7.6%
7/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Hyperglycaemia
|
1.2%
1/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
7.0%
17/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.7%
2/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
13.7%
10/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Nausea
|
3.7%
3/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
6.1%
15/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
4.1%
3/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Joint swelling
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
7.0%
17/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
6.8%
5/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Fluid retention
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.3%
13/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Injection site haemorrhage
|
7.4%
6/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.9%
7/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Diarrhoea
|
6.2%
5/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.9%
7/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
8.6%
8/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
4.3%
4/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Nasopharyngitis
|
6.2%
5/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.5%
6/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.1%
1/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.4%
5/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Sinusitis
|
4.9%
4/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
2.5%
6/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Muscle spasms
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.5%
4/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Shoulder pain
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
1.4%
1/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.5%
4/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
|
General disorders
Swelling face
|
0.00%
0/81
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/244
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/93
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/92
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
0.00%
0/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
5.5%
4/73
Safety analyses were performed on subjects who received at least one injection of study drug (Serostim® or placebo).
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER