Comparison · NCT00112385-67f481d2
Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52
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. Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52. Trial comparisons, record NCT00112385-67f481d2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00112385-67f481d2
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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 | 0.259 | wilson | |
| Risk in group 2 | 0 | 0 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.434 | 0.259 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Etanercept | Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks | 0 | 11 | OG000 |
| Group 2 | Placebo | Subjects will be given syringes containing placebo | 0 | 5 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52
- Description
The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.
- Time frame
- Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
- Population
Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
Source ClinicalTrials.gov
Trial
- Title
- A Pilot Study of Etanercept in Dermatomyositis
- NCT number
- NCT00112385
- Phases
- PHASE1
- Conditions
- Dermatomyositis
- Interventions
- Etanercept, Placebo
- Lead sponsor
- Brigham and Women's Hospital
- Results first posted
- 2011-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00112385?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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