Male vs Female: Number of Participants With Treatment-Related Adverse Events: Male vs. Female

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

Measures 6

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

Measure	Value	95% interval, lower	95% interval, upper	Method	Source
Risk in group 1	0.0116	0.00941	0.0143	wilson	ClinicalTrials.gov
Risk in group 2	0.0207	0.0174	0.0247	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	-0.00913	-0.0137	-0.00484	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	0.559	0.426	0.735	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	0.554	0.42	0.732	log	ClinicalTrials.gov
Number needed to treat, for one fewer participant with the outcome on Male than on Female	110	73.2	207	from the risk difference interval	ClinicalTrials.gov

Groups 2

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

Group	Title	Description	With the outcome	Analysed	ClinicalTrials.gov code	Source
Group 1	Male	Male participants who experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	87	7,504	OG000	ClinicalTrials.gov
Group 2	Female	Female participants who experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.	121	5,839	OG001	ClinicalTrials.gov

Outcome 5

Field	Value	Source
Type	SECONDARY	ClinicalTrials.gov
Title	Number of Participants With Treatment-Related Adverse Events: Male vs. Female	ClinicalTrials.gov
Description	To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events.	ClinicalTrials.gov
Time frame	Last day of observation period (average of 14.76 weeks)	ClinicalTrials.gov
Population	The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.	ClinicalTrials.gov

Trial 8

Field	Value	Source
Title	Amlodipine 10mg Drug Use Investigation	ClinicalTrials.gov
NCT number	NCT01252563	ClinicalTrials.gov
Phases		ClinicalTrials.gov
Conditions	Hypertension	ClinicalTrials.gov
Interventions	Amlodipine	ClinicalTrials.gov
Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	ClinicalTrials.gov
Results first posted	2019-04-02	ClinicalTrials.gov
Results on ClinicalTrials.gov	https://clinicaltrials.gov/study/NCT01252563?tab=results	ClinicalTrials.gov

Source 4

Field	Value	Source
Release	trial-comparisons-2026-03-23-0.1.0	ClinicalTrials.gov
Release manifest SHA-256	f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57	ClinicalTrials.gov
AACT copy	2026-03-23	ClinicalTrials.gov
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	ClinicalTrials.gov

The same record as JSON

Release trial-comparisons-2026-03-23-0.1.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.

ClinicalTrials.gov: none 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.