Comparison · NCT04649476-sae
Neoadjuvant PD-1 Blockade Alone vs Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy: 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. Neoadjuvant PD-1 Blockade Alone vs Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy: serious adverse events. Trial comparisons, record NCT04649476-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04649476-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 | 0.0588 | 0.0163 | 0.191 | wilson | |
| Risk in group 2 | 0.324 | 0.191 | 0.492 | wilson | |
| Risk difference, group 1 minus group 2 | -0.265 | -0.438 | -0.0778 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.182 | 0.0435 | 0.76 | log | |
| Odds ratio, group 1 over group 2 | 0.131 | 0.0264 | 0.647 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Neoadjuvant PD-1 Blockade Alone than on Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy | 3.78 | 2.28 | 12.9 | 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 | Neoadjuvant PD-1 Blockade Alone | The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.~Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery. | 2 | 34 | EG000 |
| Group 2 | Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy | The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.~Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles. | 11 | 34 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
Source ClinicalTrials.gov
Trial
- Title
- Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma
- NCT number
- NCT04649476
- Phases
- PHASE2
- Conditions
- Oral Squamous Cell Carcinoma
- Interventions
- Camrelizumab, Camrelizumanb plus TPF
- Lead sponsor
- Hospital of Stomatology, Wuhan University
- Results first posted
- 2024-04-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04649476?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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