Comparison · NCT01737281-sae
Intervention Arm vs Control Arm: 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. Intervention Arm vs Control Arm: serious adverse events. Trial comparisons, record NCT01737281-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01737281-sae
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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 | 0.0402 | 0.0296 | 0.0545 | wilson | |
| Risk in group 2 | 0.0289 | 0.0201 | 0.0414 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0114 | -0.00512 | 0.0282 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 0.864 | 2.24 | log | |
| Odds ratio, group 1 over group 2 | 1.41 | 0.86 | 2.31 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Intervention Arm than on Control Arm | 88.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention Arm | Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer. | 39 | 969 | EG000 |
| Group 2 | Control Arm | Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion. | 28 | 969 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Total adverse events were based on the results form 12 month follow-up
Source ClinicalTrials.gov
Trial
- Title
- Proactive Outreach for Smokers in VA Mental Health
- NCT number
- NCT01737281
- Phases
- NA
- Conditions
- Smoking
- Interventions
- Proactive outreach, Usual care
- Lead sponsor
- VA Office of Research and Development
- Results first posted
- 2019-03-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01737281?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.
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