Comparison · NCT04458909-sae
Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): 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. Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): serious adverse events. Trial comparisons, record NCT04458909-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04458909-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 | 0.909 | 0.623 | 0.984 | wilson | |
| Risk in group 2 | 0.5 | 0.15 | 0.85 | wilson | |
| Risk difference, group 1 minus group 2 | 0.409 | -0.0432 | 0.767 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.82 | 0.67 | 4.93 | log | |
| Odds ratio, group 1 over group 2 | 10 | 0.584 | 171 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) than on Arm II (Gemcitabine, Cisplatin / Carboplatin) | 2.44 | 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 | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | Six cycles (3 weeks each):~* Nivolumab 360 mg fixed dose IV over 30 minutes on day 1.~* Cisplatin 80 mg/m\^2 IV over 30-60 minutes or carboplatin AUC of 5 on day 1.~* Gemcitabine 1000 mg/m\^2 in IV over 30 minutes on days 1 and 8.~Followed by maintenance therapy for up to 24 cycles (4 weeks each):~* Nivolumab 480 mg fixed dose IV over 30 minutes on day 1. | 10 | 11 | EG000 |
| Group 2 | Arm II (Gemcitabine, Cisplatin / Carboplatin) | Gemcitabine and cisplatin or carboplatin as in Arm I. | 2 | 4 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
Source ClinicalTrials.gov
Trial
- Title
- Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer
- NCT number
- NCT04458909
- Phases
- PHASE3
- Conditions
Metastatic Nasopharyngeal Carcinoma, Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Metastatic Nasopharyngeal Nonkeratinizing Carcinoma, Metastatic Nasopharyngeal Undifferentiated Carcinoma, Nasopharyngeal Nonkeratinizing Carcinoma, Recurrent Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Nasopharyngeal Undifferentiated Carcinoma, Stage IV Nasopharyngeal Carcinoma AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVB Nasopharyngeal Carcinoma AJCC v8
- Interventions
- Carboplatin, Cisplatin, Gemcitabine, Nivolumab, Questionnaire Administration
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2024-09-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04458909?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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