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Comparison · NCT00625404-682eed7d

Truvada Arm vs Placebo Arm: Confirmed Grade 3 or Higher Reduction in Phosphorus

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. Truvada Arm vs Placebo Arm: Confirmed Grade 3 or Higher Reduction in Phosphorus. Trial comparisons, record NCT00625404-682eed7d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00625404-682eed7d

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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 10.04410.03310.0585wilson
Risk in group 20.03870.02860.0523wilson
Risk difference, group 1 minus group 20.00535-0.01210.023newcombe hybrid score
Risk ratio, group 1 over group 21.140.751.73log
Odds ratio, group 1 over group 21.140.7411.77log
Number needed to treat, for one more participant with the outcome on Truvada Arm than on Placebo Arm187from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Truvada ArmDaily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).451,021OG000
Group 2Placebo ArmDaily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.401,033OG001

Outcome

Type
PRIMARY
Title
Confirmed Grade 3 or Higher Reduction in Phosphorus
Description
Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL
Time frame
Through 52 weeks on product and 4 weeks post-product
Population

Source ClinicalTrials.gov

Trial

Title
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
NCT number
NCT00625404
Phases
PHASE3
Conditions
HIV Infections
Interventions
Truvada, Placebo
Lead sponsor
FHI 360
Results first posted
2014-04-16

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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