Comparison · NCT00695955-sae
Cohort 1 vs Cohort 2: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Cohort 1 vs Cohort 2: serious adverse events. Trial comparisons, record NCT00695955-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00695955-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0829 | 0.0587 | 0.116 | wilson | |
| Risk in group 2 | 0.0717 | 0.0478 | 0.106 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0112 | -0.0309 | 0.0519 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.682 | 1.96 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.66 | 2.08 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1 than on Cohort 2 | 89.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
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 |
|---|---|---|---|---|---|
| Group 1 | Cohort 1 | Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved. | 30 | 362 | EG000 |
| Group 2 | Cohort 2 | Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved. | 22 | 307 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
- NCT number
- NCT00695955
- Phases
- PHASE3
- Conditions
- Hypertension
- Interventions
- Azilsartan medoxomil with or without add-on chlorthalidone, Azilsartan medoxomil with or without add-on hydrochlorothiazide
- Lead sponsor
- Takeda
- Results first posted
- 2011-04-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00695955?tab=results
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00695955-sae