Comparison · NCT02031250-sae
Boost Arm vs Control Arm: 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. Boost Arm vs Control Arm: serious adverse events. Trial comparisons, record NCT02031250-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02031250-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 | 0.293 | 0.176 | 0.445 | wilson | |
| Risk in group 2 | 0.254 | 0.161 | 0.378 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0384 | -0.132 | 0.217 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.603 | 2.2 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.497 | 2.96 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Boost Arm than on Control Arm | 26 | 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 | Boost Arm | Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)~Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation~Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation~IMRT (Intensity-Modulated Radiation Therapy)~Boost Radiation to Hypoperfused Volumes | 12 | 41 | EG001 |
| Group 2 | Control Arm | Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)~Cisplatin: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation~Carboplatin: Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation~IMRT (Intensity-Modulated Radiation Therapy) | 15 | 59 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 3 years.
Source ClinicalTrials.gov
Trial
- Title
- Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
- NCT number
- NCT02031250
- Phases
- PHASE2
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Cisplatin, Carboplatin, IMRT (Intensity-Modulated Radiation Therapy), Boost Radiation to Hypoperfused Volumes
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Results first posted
- 2026-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02031250?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.
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GET https://conductscience.org/api/comparisons/v1/NCT02031250-sae