Cohort 2011 vs Cohort 2019: serious adverse events
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 | 0.149 | 0.139 | 0.159 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0779 | 0.0689 | 0.0881 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0706 | 0.0565 | 0.0844 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.91 | 1.66 | 2.19 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 2.06 | 1.77 | 2.41 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 2011 than on Cohort 2019 | 14.2 | 11.9 | 17.7 | 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 | Cohort 2011 | The data comprising the 2011 reference cohort were collected as part of the Collaborative Research on Ageing in Europe (COURAGE in Europe) project between July 2011 and May 2012. It consisted of a representative sample of the Spanish adult population over 50 years of age, with an oversampling of older people and a representative comparison sample of individuals aged 18-49 years. Potential respondents were selected using a stratified, multistage, stratified probability design, by clustered areas without replacement, according to Spanish regions and population size. The primary sampling unit consisted of municipalities. A number of census units (the secondary sampling unit) were chosen from each of them. Age strata were then used to randomly select 10 households within each census unit (the tertiary sampling unit). Finally, a list of household occupants was drawn up, from which one participant was randomly selected following age quotas. Institutionalized persons were not included in the initial interviews. At baseline, 4,753 participants were interviewed, of which 2,528 were interviewed in the second wave (2014-2015), 1,577 in the third wave (2010-2021) and 963 in the fourth wave (2022-2023). | 706 | 4,753 | EG000 | ClinicalTrials.gov |
| Group 2 | Cohort 2019 | The sample of the 2019 cohort is a new representative refreshment sample from the provinces of Barcelona and Madrid, to compensate for attrition (e.g., deaths, dropouts) from the 2011 cohort. Household selection was also multistage. At the primary sampling unit level, households were defined using predefined routes and an omission factor. Households were assigned to one of two age groups (i.e., household aged 18-49 years or household aged 50 years or older) and interviewers hand-delivered the invitation letter to the selected households. All residents in the eligible age group were invited to participate in the survey. In this first wave, 3 002 participants joined and in 2022 the second selection of participants for the 2019 cohort was conducted, of which 1 037 participants were interviewed. | 234 | 3,002 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | For both cohorts (2011 and 2019), data on adverse events and deaths are collected at the same time, when a new wave is carried out. Specifically for cohort 2011 adverse events have been evaluated 4 times during 12 years (2011-2012, 2014-2015, 2019-2021 and 2022-2023) and for cohort 2019 they have been evaluated 2 times during 4 years (2019-2020 and 2022-2023). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Ageing and Health. Spanish Longitudinal Study | ClinicalTrials.gov |
| NCT number | NCT03343886 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | Health, Subjective, Disability, Evaluation, Chronic Disease, Mental Disorder, Aging, Loneliness, Cognitive Decline, Well-being | ClinicalTrials.gov |
| Interventions | ClinicalTrials.gov | |
| Lead sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | ClinicalTrials.gov |
| Results first posted | 2024-10-15 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03343886?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.