Comparison · NCT04459715-sae
Sequence 1: Debio 1143 + CRT vs Sequence 2: Placebo + CRT: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Sequence 1: Debio 1143 + CRT vs Sequence 2: Placebo + CRT: serious adverse events. Trial comparisons, record NCT04459715-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04459715-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 | 0.533 | 0.482 | 0.584 | wilson | |
| Risk in group 2 | 0.362 | 0.314 | 0.414 | wilson | |
| Risk difference, group 1 minus group 2 | 0.171 | 0.0981 | 0.241 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 1.24 | 1.74 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 1.49 | 2.71 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sequence 1: Debio 1143 + CRT than on Sequence 2: Placebo + CRT | 5.86 | 4.16 | 10.2 | 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 | Sequence 1: Debio 1143 + CRT | Participants received a combination of Debio 1143 along with Chemoradiotherapy (CRT): Radiotherapy +Cisplatin + Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles (combination therapy period). If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (monotherapy period). | 194 | 364 | EG000 |
| Group 2 | Sequence 2: Placebo + CRT | Participants received a combination of placebo matched to Debio 1143 along with Chemoradiotherapy(CRT): Radiotherapy +Cisplatin+ placebo matched to Xevinapant (Debio 1143). Participants received 6 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14, per 3-week cycle in combination with 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 fractions, 2 Gy/fraction, over 7 weeks, and High-dose cisplatin (100 mg/m2) on Day 2 of a 3-week cycle per 3 cycles(combination therapy period).If high-dose cisplatin 100 mg/m2 was not tolerated after the first dose, participants could be switched to carboplatin (10mg/mL, iv infusion), followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (monotherapy period). | 129 | 356 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All AEs and All-Cause Mortality were be collected from the time of Informed Consent Form signature until the End Of Treatment (EOT) visit (Day 134) . From the EOT visit until the End Of Study visit (Up to 44 months), only All-Cause Mortality, SAEs and late onset Adverse Events of Special Interest were collected
Source ClinicalTrials.gov
Trial
- Title
A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
- NCT number
- NCT04459715
- Phases
- PHASE3
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Xevinapant (Debio 1143), Cisplatin, Intensity Modulation Radiation Therapy (IMRT), Placebo
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Results first posted
- 2025-10-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04459715?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
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