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Comparison · NCT01263717-sae

Tesamorelin vs Placebo (Inactive Injection): serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Tesamorelin vs Placebo (Inactive Injection): serious adverse events. Trial comparisons, record NCT01263717-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01263717-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1070.03710.272wilson
Risk in group 20.1360.04750.333wilson
Risk difference, group 1 minus group 2-0.0292-0.2380.158newcombe hybrid score
Risk ratio, group 1 over group 20.7860.1753.52log
Odds ratio, group 1 over group 20.760.1384.19log
Number needed to treat, for one fewer participant with a serious adverse event on Tesamorelin than on Placebo (Inactive Injection)34.2from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1TesamorelinTesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose328EG000
Group 2Placebo (Inactive Injection)Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase322EG001

Harm

What it counts
Total, serious adverse events
Time frame
6 month randomized portion of study

Source ClinicalTrials.gov

Trial

Title
Effects of Growth Hormone Releasing Hormone in HIV
NCT number
NCT01263717
Phases
NA
Conditions
HIV, HIV Lipodystrophy
Interventions
tesamorelin, placebo
Lead sponsor
Massachusetts General Hospital
Results first posted
2014-10-13

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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