Comparison · NCT01085903-sae
Normal Subjects vs Stroke Subjects: 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. Normal Subjects vs Stroke Subjects: serious adverse events. Trial comparisons, record NCT01085903-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01085903-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 | 0 | 0.155 | wilson | |
| Risk in group 2 | 0.286 | 0.0822 | 0.641 | wilson | |
| Risk difference, group 1 minus group 2 | -0.286 | -0.641 | -0.0301 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Normal Subjects than on Stroke Subjects | 3.5 | 1.56 | 33.2 | from the risk difference interval |
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 | Normal Subjects | Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months | 0 | 21 | EG000 |
| Group 2 | Stroke Subjects | Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months | 2 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years
Source ClinicalTrials.gov
Trial
- Title
- Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
- NCT number
- NCT01085903
- Phases
- PHASE2
- Conditions
- Spatial Neglect, Dysphagia
- Interventions
- Modafinil, Placebo, Baseline, CPS, Post CPS, Follow up
- Lead sponsor
- University of Arkansas
- Results first posted
- 2016-10-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01085903?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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