Comparison · NCT01168973-sae
Ramucirumab and Docetaxel vs Placebo and Docetaxel: 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. Ramucirumab and Docetaxel vs Placebo and Docetaxel: serious adverse events. Trial comparisons, record NCT01168973-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01168973-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 | 0.453 | 0.414 | 0.492 | wilson | |
| Risk in group 2 | 0.455 | 0.416 | 0.494 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00174 | -0.0569 | 0.0534 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.996 | 0.882 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.993 | 0.794 | 1.24 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ramucirumab and Docetaxel than on Placebo and Docetaxel | 574 | 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 | Ramucirumab and Docetaxel | On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~* Ramucirumab DP: 10 mg/kg administered intravenously.~* Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously. | 284 | 627 | EG000 |
| Group 2 | Placebo and Docetaxel | On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~* Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~* Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously. | 281 | 618 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomization through 30 days following last infusion (up to Cycle 38, 21 days/cycle).
Source ClinicalTrials.gov
Trial
- Title
- A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy
- NCT number
- NCT01168973
- Phases
- PHASE3
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Ramucirumab, Placebo (for Ramucirumab), Docetaxel
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2014-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01168973?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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