Comparison · NCT00117572-sae
Induction Plus Chemoradiotherapy vs Chemoradiotherapy: 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. Induction Plus Chemoradiotherapy vs Chemoradiotherapy: serious adverse events. Trial comparisons, record NCT00117572-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00117572-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 | 0.471 | 0.39 | 0.554 | wilson | |
| Risk in group 2 | 0.281 | 0.212 | 0.363 | wilson | |
| Risk difference, group 1 minus group 2 | 0.19 | 0.0747 | 0.297 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 1.21 | 2.31 | log | |
| Odds ratio, group 1 over group 2 | 2.27 | 1.38 | 3.76 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Induction Plus Chemoradiotherapy than on Chemoradiotherapy | 5.28 | 3.36 | 13.4 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Induction Plus Chemoradiotherapy | Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details | 65 | 138 | EG000 |
| Group 2 | Chemoradiotherapy | Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details | 38 | 135 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 years
Source ClinicalTrials.gov
Trial
- Title
- Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
- NCT number
- NCT00117572
- Phases
- PHASE3
- Conditions
- Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity
- Interventions
- docetaxel, cisplatin, hydroxyurea, fluorouracil, chemotherapy, radiotherapy
- Lead sponsor
- University of Chicago
- Results first posted
- 2018-04-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00117572?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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