Comparison · NCT01774786-sae
Pertuzumab + Trastuzumab + Chemotherapy vs Placebo + Trastuzumab + 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. Pertuzumab + Trastuzumab + Chemotherapy vs Placebo + Trastuzumab + Chemotherapy: serious adverse events. Trial comparisons, record NCT01774786-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01774786-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 | 0.462 | 0.413 | 0.512 | wilson | |
| Risk in group 2 | 0.402 | 0.354 | 0.452 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0603 | -0.00952 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.978 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 1.28 | 0.962 | 1.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pertuzumab + Trastuzumab + Chemotherapy than on Placebo + Trastuzumab + Chemotherapy | 16.6 | 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 | Pertuzumab + Trastuzumab + Chemotherapy | Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. | 178 | 385 | EG000 |
| Group 2 | Placebo + Trastuzumab + Chemotherapy | Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. | 156 | 388 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline until end of post-treatment follow-up (up to 70 months)
Source ClinicalTrials.gov
Trial
- Title
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
- NCT number
- NCT01774786
- Phases
- PHASE3
- Conditions
- Gastric Cancer
- Interventions
- 5-Fluorouracil, Capecitabine, Cisplatin, Pertuzumab, Placebo, Trastuzumab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2018-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01774786?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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