Trial Outcomes & Findings for Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons (NCT NCT02572323)
NCT ID: NCT02572323
Last Updated: 2026-03-12
Results Overview
The primary outcome was neurocognitive (NC) change, measured by the summary regression-based change score (sRCS), derived from a comprehensive battery assessing seven NC domains using the Global Deficit Score (GDS). The sRCS is calculated as a z-score from regression model residuals between baseline and week 24, adjusting for practice effects, statistical artifacts, and demographics. Altogether, 15 individual z scores are computed, by dividing the difference between predicted (Xp) and obtained (Xo) follow-up scaled scores by the error term of the regression model (Xo-Xp/SD-residual) and then averaged to generate the sRCS. Scores center around 0 (no change), with negative scores indicating decline and positive scores improvement. Significant changes are defined by 90% confidence intervals (±1.645 SD) such that participants in the top 5% of the sRCS distribution of the normative, stable reference sample were defined as "improved," and the bottom 5% were defined the "decliners."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Baseline and week 24
Results posted on
2026-03-12
Participant Flow
Participant milestones
| Measure |
Immediate Group
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Deferred Group
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
30
|
|
Overall Study
COMPLETED
|
42
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Immediate Group
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Deferred Group
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
Baseline characteristics by cohort
| Measure |
Immediate Group
n=43 Participants
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Deferred Group
n=30 Participants
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 8.5 • n=9 Participants
|
57.4 years
STANDARD_DEVIATION 10.8 • n=9 Participants
|
58.6 years
STANDARD_DEVIATION 9.5 • n=18 Participants
|
|
Sex/Gender, Customized
Sex, female
|
6 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
8 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Sex, male
|
37 Participants
n=9 Participants
|
28 Participants
n=9 Participants
|
65 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=9 Participants
|
10 Participants
n=9 Participants
|
26 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
24 Participants
n=9 Participants
|
17 Participants
n=9 Participants
|
41 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Nadir CD4, Continuous
|
200 cells/μl
n=9 Participants
|
187 cells/μl
n=9 Participants
|
200 cells/μl
n=18 Participants
|
|
Current CD4, Continuous
|
651 cells/μl
n=9 Participants
|
763 cells/μl
n=9 Participants
|
707 cells/μl
n=18 Participants
|
|
On Antiretroviral Therapy (ART), Categorical
|
43 Participants
n=9 Participants
|
30 Participants
n=9 Participants
|
73 Participants
n=18 Participants
|
|
Regimen Type, Categorical
PI/NRTI
|
5 Participants
n=9 Participants
|
16 Participants
n=9 Participants
|
21 Participants
n=18 Participants
|
|
Regimen Type, Categorical
NRTI/II
|
20 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
20 Participants
n=18 Participants
|
|
Regimen Type, Categorical
NNRTI/NRTI
|
4 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
13 Participants
n=18 Participants
|
|
Regimen Type, Categorical
3-class
|
6 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
6 Participants
n=18 Participants
|
|
Regimen Type, Categorical
Other
|
4 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Regimen Type, Categorical
Missing
|
4 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Global Deficit Score (GDS), Continuous
|
0.67 units on a scale
n=9 Participants
|
0.75 units on a scale
n=9 Participants
|
0.706 units on a scale
n=18 Participants
|
|
Waist Circumference, Continuous
|
110 cm
n=9 Participants
|
109 cm
n=9 Participants
|
110 cm
n=18 Participants
|
|
Beck Depression Inventory-II (BDI-II), Continuous
|
12.5 units on a scale
n=9 Participants
|
16.5 units on a scale
n=9 Participants
|
14.5 units on a scale
n=18 Participants
|
|
Patient's Assessment of Own Functioning (PAOFI), Continuous
|
6 Units on a scale
n=9 Participants
|
8 Units on a scale
n=9 Participants
|
7 Units on a scale
n=18 Participants
|
|
Instrumental Activities of Daily Living (IADLs), Continuous
|
0.01 units on a scale
n=9 Participants
|
.01 units on a scale
n=9 Participants
|
.01 units on a scale
n=18 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 24Population: neurocognitively impaired abdominally obese people with HIV (PWH)
The primary outcome was neurocognitive (NC) change, measured by the summary regression-based change score (sRCS), derived from a comprehensive battery assessing seven NC domains using the Global Deficit Score (GDS). The sRCS is calculated as a z-score from regression model residuals between baseline and week 24, adjusting for practice effects, statistical artifacts, and demographics. Altogether, 15 individual z scores are computed, by dividing the difference between predicted (Xp) and obtained (Xo) follow-up scaled scores by the error term of the regression model (Xo-Xp/SD-residual) and then averaged to generate the sRCS. Scores center around 0 (no change), with negative scores indicating decline and positive scores improvement. Significant changes are defined by 90% confidence intervals (±1.645 SD) such that participants in the top 5% of the sRCS distribution of the normative, stable reference sample were defined as "improved," and the bottom 5% were defined the "decliners."
Outcome measures
| Measure |
Immediate Group
n=43 Participants
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Deferred Group
n=30 Participants
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
|---|---|---|
|
Change in Neurocognitive Performance
|
0.146 Z-score
Interval -0.002 to 0.294
|
0.103 Z-score
Interval -0.095 to 0.301
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: neurocognitively impaired abdominally obese people with HIV (PWH)
Change in Insulin-like growth factor 1 (IGF-1), a biomarker of visceral adipose tissue (VAT)-related inflammation and immune activation, from baseline to week 24
Outcome measures
| Measure |
Immediate Group
n=43 Participants
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Deferred Group
n=30 Participants
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
|---|---|---|
|
Insulin-like Growth Factor 1 (IGF-1)
|
53.2 % increase in IGF-1 from week 0 to 24
Interval 32.8 to 76.8
|
5.3 % increase in IGF-1 from week 0 to 24
Interval -2.7 to 13.9
|
Adverse Events
Immediate Group
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Deferred Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Group
n=43 participants at risk
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Deferred Group
n=30 participants at risk
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdomen/Groin/Pelvis Skin cancer
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
Other adverse events
| Measure |
Immediate Group
n=43 participants at risk
1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
Deferred Group
n=30 participants at risk
No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months
Tesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
|
|---|---|---|
|
Endocrine disorders
Fasting glucose
|
16.3%
7/43 • Number of events 7 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
16.7%
5/30 • Number of events 5 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Nervous system disorders
Numbness
|
7.0%
3/43 • Number of events 3 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Injection Site Bruising
|
14.0%
6/43 • Number of events 6 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Cardiac disorders
Blood Pressure elevated
|
9.3%
4/43 • Number of events 4 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
16.7%
5/30 • Number of events 5 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Injection site itchiness
|
9.3%
4/43 • Number of events 4 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Renal and urinary disorders
Creatinine clearance
|
9.3%
4/43 • Number of events 4 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
10.0%
3/30 • Number of events 3 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Hepatobiliary disorders
AST/SGOT
|
11.6%
5/43 • Number of events 5 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
6.7%
2/30 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
7.0%
3/43 • Number of events 3 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Nervous system disorders
Paresthesia
|
9.3%
4/43 • Number of events 4 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Renal and urinary disorders
Creatinine
|
7.0%
3/43 • Number of events 3 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Hepatobiliary disorders
Alanine Amino Transferase
|
7.0%
3/43 • Number of events 3 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
6.7%
2/30 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.9%
9/43 • Number of events 9 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
50.0%
15/30 • Number of events 15 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
14.0%
6/43 • Number of events 6 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
16.7%
5/30 • Number of events 5 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Edema
|
20.9%
9/43 • Number of events 9 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
13.3%
4/30 • Number of events 4 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Injection site burning
|
4.7%
2/43 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Endocrine disorders
abnormal non-fasting glucose
|
27.9%
12/43 • Number of events 12 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
16.7%
5/30 • Number of events 5 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Gastrointestinal disorders
Fasting triglycerides
|
4.7%
2/43 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Abdomen bruising
|
4.7%
2/43 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
6.7%
2/30 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Hepatobiliary disorders
Abnormal bilirubin
|
4.7%
2/43 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Gastrointestinal disorders
Stomach inflammation/distension
|
7.0%
3/43 • Number of events 3 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
General disorders
Lethargy
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Psychiatric disorders
Depression
|
4.7%
2/43 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Psychiatric disorders
Confusion
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Metabolism and nutrition disorders
Abnormal potassium
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Metabolism and nutrition disorders
Weight gain
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Metabolism and nutrition disorders
Loss of appetite
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Nervous system disorders
Sleep problems
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Tenderness
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Immune system disorders
Fever
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Immune system disorders
CD4 count decreased
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
7.0%
3/43 • Number of events 3 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Abdomen Itchiness
|
4.7%
2/43 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Cardiac disorders
Fainting
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Cardiac disorders
Cardiovascular disorder
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Metabolism and nutrition disorders
Abnormal Calcium
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Abdomen tightness
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
Abdomen erythema
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Fractured hip
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Hand/finger inflammation
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Gastrointestinal disorders
Intestinal pain
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Skin and subcutaneous tissue disorders
skin abnormality
|
4.7%
2/43 • Number of events 2 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
hand/finger contraction
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Metabolism and nutrition disorders
Appetite loss
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Gastrointestinal disorders
Gastrointestinal dysfunction
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lump on abdomen
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory system dysfunction
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Nervous system disorders
Neurologic dysfunctiom
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Infections and infestations
Foot osteomyelitis
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Immune system disorders
Leg rash
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Immune system disorders
Abdomen urticaria
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Cardiac disorders
Hemoglobin
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Cardiac disorders
Low Blood Pressure
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Endocrine disorders
Fasting total cholesterol
|
0.00%
0/43 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
3.3%
1/30 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Endocrine disorders
Dry mouth
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
|
Psychiatric disorders
Psychiatric changes
|
2.3%
1/43 • Number of events 1 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
0.00%
0/30 • 48 weeks
The following adverse events reflect those of participants in the Immediate arm from baseline to week 24 during the primary study period with follow up at week 48 and adverse events for the deferred arm from week 24 to week 48. Adverse events were not monitored/assessed for the Deferred group from baseline to week 24.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place