Comparison · NCT03504397-556a9e55
mFOLFOX6 + Zolbetuximab vs mFOLFOX6+ Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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. mFOLFOX6 + Zolbetuximab vs mFOLFOX6+ Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs). Trial comparisons, record NCT03504397-556a9e55. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03504397-556a9e55
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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 | 0.996 | 0.98 | 0.999 | wilson | |
| Risk in group 2 | 0.996 | 0.98 | 0.999 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0000129 | -0.0167 | 0.0168 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.99 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0625 | 16.1 | log | |
| Number needed to treat, for one more participant with the outcome on mFOLFOX6 + Zolbetuximab than on mFOLFOX6+ Placebo | 77,600 | 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 | mFOLFOX6 + Zolbetuximab | Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days. | 278 | 279 | OG000 |
| Group 2 | mFOLFOX6+ Placebo | Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days. | 277 | 278 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- Description
An Adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or notconsidered related to the medicinal product. TEAE defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
- Time frame
- From first dose until 62 months and 18 days
- Population
- Safety analysis set (SAF) included all participants who received at least 1 dose of any study drug (zolbetuximab/placebo and mFOLFOX6).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
- NCT number
- NCT03504397
- Phases
- PHASE3
- Conditions
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Interventions
- zolbetuximab, placebo, oxaliplatin, folinic acid, fluorouracil
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Results first posted
- 2025-02-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03504397?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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