Comparison · NCT02393690-sae
Arm I (Selumetinib, Iodine I-131) vs Arm II (Placebo, Iodine I-131): 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. Arm I (Selumetinib, Iodine I-131) vs Arm II (Placebo, Iodine I-131): serious adverse events. Trial comparisons, record NCT02393690-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02393690-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 | 0.0714 | 0.0198 | 0.226 | wilson | |
| Risk in group 2 | 0.0333 | 0.00591 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0381 | -0.105 | 0.196 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.14 | 0.205 | 22.3 | log | |
| Odds ratio, group 1 over group 2 | 2.23 | 0.191 | 26.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Selumetinib, Iodine I-131) than on Arm II (Placebo, Iodine I-131) | 26.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm I (Selumetinib, Iodine I-131) | Patients receive 75 mg selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO. | 2 | 28 | EG000 |
| Group 2 | Arm II (Placebo, Iodine I-131) | Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO. | 1 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected at the end of each 28 day cycle. The max number of cycles taken was 8.
Source ClinicalTrials.gov
Trial
- Title
- Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
- NCT number
- NCT02393690
- Phases
- PHASE2
- Conditions
Metastatic Thyroid Gland Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Carcinoma, Stage IV Thyroid Gland Follicular Carcinoma AJCC v7, Stage IV Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7
- Interventions
- Iodine I-131, Placebo Administration, Selumetinib
- Lead sponsor
- Academic and Community Cancer Research United
- Results first posted
- 2021-08-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02393690?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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