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Comparison · NCT00215644-sae

Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab vs ECX Only: 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. Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab vs ECX Only: serious adverse events. Trial comparisons, record NCT00215644-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00215644-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.000000000000000006940.0989wilson
Risk in group 2000.0964wilson
Risk difference, group 1 minus group 20-0.09640.0989newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m\^2, cisplatin 60 mg/m\^2 on Day 1 and capecitabine 1250 mg/m\^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day.
035EG000
Group 2ECX Only
Participants received epirubicin 50 mg/m\^2, cisplatin 60 mg/m\^2 on Day 1 and capecitabine 1250 mg/m\^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn.
036EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
NCT number
NCT00215644
Phases
PHASE2
Conditions
Esophageal Cancer, Gastric Cancer
Interventions
Matuzumab, Epirubicin, Cisplatin, Capecitabine
Lead sponsor
Merck KGaA, Darmstadt, Germany
Results first posted
2018-11-02

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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