Comparison · NCT01711658-sae
IMRT + Cisplatin + Placebo vs IMRT + Cisplatin + Lapatinib: 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. IMRT + Cisplatin + Placebo vs IMRT + Cisplatin + Lapatinib: serious adverse events. Trial comparisons, record NCT01711658-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01711658-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 | 0.441 | 0.322 | 0.567 | wilson | |
| Risk in group 2 | 0.517 | 0.393 | 0.638 | wilson | |
| Risk difference, group 1 minus group 2 | -0.076 | -0.246 | 0.101 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.853 | 0.585 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.737 | 0.358 | 1.52 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on IMRT + Cisplatin + Placebo than on IMRT + Cisplatin + Lapatinib | 13.2 | from the risk difference interval | the interval includes no difference |
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 | IMRT + Cisplatin + Placebo | IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29~Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT | 26 | 59 | EG000 |
| Group 2 | IMRT + Cisplatin + Lapatinib | IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy~Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29~Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT | 31 | 60 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
Source ClinicalTrials.gov
Trial
- Title
- TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
- NCT number
- NCT01711658
- Phases
- PHASE2
- Conditions
- Non-HPV Locally Advanced Head and Neck Cancer
- Interventions
- IMRT, Cisplatin, placebo, Lapatinib
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2021-11-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01711658?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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