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Comparison · NCT01107743-c8bcbab3

<65 Years vs >=65 Years: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.

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. <65 Years vs >=65 Years: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. Trial comparisons, record NCT01107743-c8bcbab3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01107743-c8bcbab3

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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 10.01330.005680.0307wilson
Risk in group 20.0150.008770.0255wilson
Risk difference, group 1 minus group 2-0.00171-0.01460.0168newcombe hybrid score
Risk ratio, group 1 over group 20.8860.3182.47log
Odds ratio, group 1 over group 20.8840.3132.5log
Number needed to treat, for one fewer participant with the outcome on <65 Years than on >=65 Years583from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1<65 YearsParticipants with \<65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.5377OG000
Group 2>=65 YearsParticipants with \>=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.13868OG001

Outcome

Type
SECONDARY
Title
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
Description
Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 years is significant risk factor.
Time frame
8 weeks
Population
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Source ClinicalTrials.gov

Trial

Title
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT number
NCT01107743
Phases
Conditions
Hypertension, Angina Pectoris, Hypercholesterolemia, Familial Hypercholesterolemia
Interventions
Amlodipine/Atorvastatin
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Results first posted
2013-05-30

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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