Comparison · NCT01890915-sae
Tetraplegia vs Control: 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. Tetraplegia vs Control: serious adverse events. Trial comparisons, record NCT01890915-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01890915-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 | 0.0909 | 0.0162 | 0.377 | wilson | |
| Risk in group 2 | 0 | 0 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | -0.196 | 0.377 | 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 harm, for one more participant with a serious adverse event on Tetraplegia than on Control | 11 | 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 | Tetraplegia | Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours. | 1 | 11 | EG000 |
| Group 2 | Control | Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours. | 0 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were reported within five business days to the VA's Institutional Review Board (IRB) via an Adverse Event form and were also included on the Adverse Events log on the annual continuing review application in accordance with VA IRB policy.
Source ClinicalTrials.gov
Trial
- Title
- Body Temperature in Persons With Tetraplegia When Exposed to Heat
- NCT number
- NCT01890915
- Phases
- Conditions
- Spinal Cord Injury
- Interventions
- Heat Exposure
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Results first posted
- 2016-03-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01890915?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
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