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Comparison · NCT00294047-d0e0323a

Cervarix Group vs Aluminium Hydroxide Group: Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.

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. Cervarix Group vs Aluminium Hydroxide Group: Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study. Trial comparisons, record NCT00294047-d0e0323a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00294047-d0e0323a

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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 10.009730.006740.014wilson
Risk in group 20.004880.002910.00817wilson
Risk difference, group 1 minus group 20.004850.0004060.00958newcombe hybrid score
Risk ratio, group 1 over group 221.053.78log
Odds ratio, group 1 over group 221.053.82log
Number needed to treat, for one more participant with the outcome on Cervarix Group than on Aluminium Hydroxide Group2061042,460from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cervarix GroupSubjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.282,877OG000
Group 2Aluminium Hydroxide Group
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
142,870OG001

Outcome

Type
SECONDARY
Title
Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame
Up to Month 84
Population
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

Source ClinicalTrials.gov

Trial

Title
Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older
NCT number
NCT00294047
Phases
PHASE3
Conditions
Infections, Papillomavirus, Papillomavirus Vaccines
Interventions
Cervarix, Placebo control
Lead sponsor
GlaxoSmithKline
Results first posted
2012-03-27

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.govNone 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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