Trial Outcomes & Findings for Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance (NCT NCT00130286)
NCT ID: NCT00130286
Last Updated: 2014-02-13
Results Overview
Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
77 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-02-13
Participant Flow
Participant milestones
| Measure |
rhGH + Rosi
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
19
|
17
|
19
|
|
Overall Study
COMPLETED
|
22
|
16
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
rhGH + Rosi
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
|
Overall Study
Missing lab specimens
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
Baseline characteristics by cohort
| Measure |
rhGH + Rosi
n=22 Participants
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
n=19 Participants
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
n=17 Participants
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
n=19 Participants
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 9.4 • n=93 Participants
|
49.3 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
48.6 years
STANDARD_DEVIATION 4.9 • n=27 Participants
|
46.6 years
STANDARD_DEVIATION 6.7 • n=483 Participants
|
47.9 years
STANDARD_DEVIATION 7.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
60 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
49 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
47 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 12 weeksChange in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points.
Outcome measures
| Measure |
rhGH + Rosi
n=22 Participants
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
n=16 Participants
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
n=13 Participants
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
n=17 Participants
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
|---|---|---|---|---|
|
Change in Insulin Sensitivity
|
0.20 uU*10^-4*min*ml^-1
Interval -0.37 to 1.0
|
1.44 uU*10^-4*min*ml^-1
Interval 0.68 to 2.59
|
-0.63 uU*10^-4*min*ml^-1
Interval -1.03 to 0.11
|
0.14 uU*10^-4*min*ml^-1
Interval -0.41 to 1.21
|
SECONDARY outcome
Timeframe: 12 weeksChange in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Outcome measures
| Measure |
rhGH + Rosi
n=20 Participants
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
n=15 Participants
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
n=11 Participants
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
n=16 Participants
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
|---|---|---|---|---|
|
Change in Visceral Adipose Tissue Volume
|
-1.13 L
Standard Deviation 1.41
|
-0.19 L
Standard Deviation 0.69
|
-1.15 L
Standard Deviation 0.81
|
-0.04 L
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 12 weeksChange in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Outcome measures
| Measure |
rhGH + Rosi
n=20 Participants
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
n=15 Participants
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
n=11 Participants
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
n=16 Participants
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
|---|---|---|---|---|
|
Change in Subcutaneous Adipose Tissue Volume
|
-0.11 L
Standard Deviation 3.33
|
0.74 L
Standard Deviation 1.86
|
-0.38 L
Standard Deviation 1.23
|
-0.03 L
Standard Deviation 2.64
|
Adverse Events
rhGH + Rosi
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
rhGH Placebo + Rosi
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
rhGH + Rosi Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Double Placebo
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rhGH + Rosi
n=22 participants at risk
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
n=18 participants at risk；n=19 participants at risk
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
n=15 participants at risk；n=17 participants at risk
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
n=17 participants at risk；n=19 participants at risk
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
|---|---|---|---|---|
|
Nervous system disorders
Delirium
|
4.5%
1/22 • Number of events 1
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/19
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/19
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Injury, poisoning and procedural complications
Study drug overdose
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.3%
1/19 • Number of events 1
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/19
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Infections and infestations
Fever of undetermined origin
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/19
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.3%
1/19 • Number of events 1
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Nervous system disorders
Leg weakness and pain
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/19
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.3%
1/19 • Number of events 1
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Renal and urinary disorders
Ureteral obstruction
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/19
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.3%
1/19 • Number of events 1
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
Other adverse events
| Measure |
rhGH + Rosi
n=22 participants at risk
Recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH Placebo + Rosi
n=18 participants at risk；n=19 participants at risk
Placebo for recombinant human growth hormone + rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
rhGH + Rosi Placebo
n=15 participants at risk；n=17 participants at risk
Recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
Double Placebo
n=17 participants at risk；n=19 participants at risk
Placebo for recombinant human growth hormone + placebo for rosiglitazone
Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
|
|---|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
6.7%
1/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
General disorders
Fatigue
|
31.8%
7/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
33.3%
6/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
33.3%
5/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
29.4%
5/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
General disorders
Weight gain
|
4.5%
1/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
6.7%
1/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
General disorders
Headache
|
13.6%
3/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.1%
2/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
20.0%
3/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.8%
7/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
22.2%
4/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
33.3%
5/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
29.4%
5/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
4.5%
1/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
20.0%
3/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.3%
6/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
22.2%
4/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
40.0%
6/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
17.6%
3/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Nervous system disorders
Parethesias
|
22.7%
5/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
26.7%
4/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
4/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
22.2%
4/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
26.7%
4/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
13.3%
2/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
17.6%
3/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Endocrine disorders
Hyperglycemia
|
22.7%
5/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
53.3%
8/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Hepatobiliary disorders
Increased ALT
|
9.1%
2/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.1%
2/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Hepatobiliary disorders
Increased AST
|
4.5%
1/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.1%
2/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
6.7%
1/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.9%
1/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.9%
1/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
17.6%
3/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
13.3%
2/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.9%
1/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Musculoskeletal and connective tissue disorders
Edema
|
54.5%
12/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
16.7%
3/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
73.3%
11/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
Reproductive system and breast disorders
Breast enlargement/tenderness
|
18.2%
4/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
5.6%
1/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
|
General disorders
Cough/upper respiratory infection
|
0.00%
0/22
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
0.00%
0/18
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
13.3%
2/15
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
11.8%
2/17
The denominator for adverse events by treatment arm reflects the number of subjects who initiated study treatment in each arm. The denominator for serious adverse events reflects the number of randomized subjects since one serious adverse event occurred in someone who never initiated study drugs. Therefore the denominators differ.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place