With Complication(s) vs Without Complication(s): Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)
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 | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0185 | 0.016 | 0.0215 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00912 | 0.00665 | 0.0125 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0094 | 0.00517 | 0.0133 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 2.03 | 1.43 | 2.88 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 2.05 | 1.44 | 2.92 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on With Complication(s) than on Without Complication(s) | 106 | 75.4 | 194 | 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 | With Complication(s) | Participants who had at least one complication and 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. | 170 | 9,177 | OG000 | ClinicalTrials.gov |
| Group 2 | Without Complication(s) | Participants who had no complication and 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. | 38 | 4,166 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) | ClinicalTrials.gov |
| Description | To determine whether having complication(s) was a significant risk factor likely to affect the frequency of treatment-related adverse events. Complications included dyslipidemia, diabetes mellitus, metabolic syndrome, chronic kidney disease, angina pectoris, cerebrovascular disease, and myocardial infarction. | 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 |
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.