Comparison · NCT00189488-sae
Palifermin vs Placebo: 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. Palifermin vs Placebo: serious adverse events. Trial comparisons, record NCT00189488-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00189488-sae
On this page
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 | 0.641 | 0.53 | 0.739 | wilson | |
| Risk in group 2 | 0.548 | 0.434 | 0.657 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0931 | -0.0623 | 0.243 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.896 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.767 | 2.83 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Palifermin than on Placebo | 10.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Palifermin | Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. | 50 | 78 | EG001 |
| Group 2 | Placebo | Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose. | 40 | 73 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 125 Days
Source ClinicalTrials.gov
Trial
- Title
Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation
- NCT number
- NCT00189488
- Phases
- PHASE2
- Conditions
- Graft Versus Host Disease, Hematologic Malignancies
- Interventions
- Palifermin, Placebo, Conditioning Regimen, Allogeneic stem cell transplant, Methotrexate
- Lead sponsor
- Swedish Orphan Biovitrum
- Results first posted
- 2014-09-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00189488?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00189488-sae