Comparison · NCT03136445-16a39133
Intervention Arm vs Control Arm: Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment.
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: Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment. Trial comparisons, record NCT03136445-16a39133. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03136445-16a39133
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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 | 0.01 | 0.00341 | 0.029 | wilson | |
| Risk in group 2 | 0.00673 | 0.00185 | 0.0242 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00327 | -0.0154 | 0.0229 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.49 | 0.25 | 8.82 | log | |
| Odds ratio, group 1 over group 2 | 1.49 | 0.247 | 8.98 | log | |
| Number needed to treat, for one more participant with the outcome on Intervention Arm than on Control Arm | 306 | 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 | Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.~Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid. | 3 | 300 | OG000 |
| Group 2 | Control Arm | Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.~Placebo: IV (saline) or oral placebo tablets | 2 | 297 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment.
- Description
Measured by calculating number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of Treatment Day 1 i.e the first day that the IMP is administered.
- Time frame
- Up to and including 60 days from the first administration of IMP.
- Population
Source ClinicalTrials.gov
Trial
- Title
- TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
- NCT number
- NCT03136445
- Phases
- PHASE3
- Conditions
- Hematologic Neoplasms, Hemorrhage, Hematopoietic Stem Cell Transplantation
- Interventions
- Tranexamic acid (TXA)., Placebo
- Lead sponsor
- NHS Blood and Transplant
- Results first posted
- 2025-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03136445?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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