Comparison · NCT02589522-sae
Group 1 - Dose Level 1 vs Group 1 - Dose Level 2: 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. Group 1 - Dose Level 1 vs Group 1 - Dose Level 2: serious adverse events. Trial comparisons, record NCT02589522-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02589522-sae
On this page
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 | 0.556 | 0.267 | 0.811 | wilson | |
| Risk in group 2 | 0 | 0 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0.556 | -0.163 | 0.811 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Group 1 - Dose Level 1 than on Group 1 - Dose Level 2 | 1.8 | 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 | Group 1 - Dose Level 1 | Patients undergo whole-brain radiation therapy Monday through Friday for 3 weeks for a total of 15 fractions. Patients also receive berzosertib 50 mg by infusion over 60-90 minutes twice a week, 18-30 hours after first radiation therapy. | 5 | 9 | EG000 |
| Group 2 | Group 1 - Dose Level 2 | Patients undergo whole-brain radiation therapy Monday through Friday for 3 weeks for a total of 15 fractions. Patients also receive berzosertib 100 mg by infusion over 60-90 minutes twice a week, 18-30 hours after first radiation therapy. | 0 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 2 years
Source ClinicalTrials.gov
Trial
- Title
Testing the Safety of M6620 (VX-970) When Given With Standard Whole Brain Radiation Therapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer, Small Cell Lung Cancer, or Neuroendocrine Tumors
- NCT number
- NCT02589522
- Phases
- PHASE1
- Conditions
Metastatic Lung Neuroendocrine Neoplasm, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
- Interventions
- Berzosertib, Quality-of-Life Assessment, Therapeutic Conventional Surgery, Whole-Brain Radiotherapy
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-05-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02589522?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02589522-sae