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Comparison · NCT01572844-sae

Treatment Lesion vs No Treatment Lesion: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Treatment Lesion vs No Treatment Lesion: serious adverse events. Trial comparisons, record NCT01572844-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01572844-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.00000000000000005550.561wilson
Risk in group 200.00000000000000005550.561wilson
Risk difference, group 1 minus group 20-0.5610.561newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: no treatment.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Treatment Lesion
Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.~Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.~Subjects will receive a total of 8-10 treatments over a 6 month period.
03EG000
Group 2No Treatment LesionLesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.03EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis
NCT number
NCT01572844
Phases
PHASE2
Conditions
Calcinosis
Interventions
Fractionated Carbon Dioxide (FCO2) Laser, Sodium thiosulfate
Lead sponsor
Alison Ehrlich
Results first posted
2017-11-29

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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