Comparison · NCT02917629-sae
Group I (ACTOplus Met XR) vs Group II (Placebo): 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 I (ACTOplus Met XR) vs Group II (Placebo): serious adverse events. Trial comparisons, record NCT02917629-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02917629-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 | 0 | 0.49 | wilson | |
| Risk in group 2 | 0 | 0 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.49 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Group I (ACTOplus Met XR) | Patients receive ACTOplus met XR PO QD for 10-21 days in the absence of disease progression or unacceptable toxicity. Patients may continue ACTOplus met XR PO QD for a maximum of 25 days if end of treatment biopsy/surgical treatment is delayed beyond day 22.~Laboratory Biomarker Analysis: Correlative studies~Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet: Given PO~Pharmacological Study: Correlative studies | 0 | 4 | EG000 |
| Group 2 | Group II (Placebo) | Patients receive placebo PO QD daily for 10-21 days.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO | 0 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 22 days
Source ClinicalTrials.gov
Trial
- Title
- ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment
- NCT number
- NCT02917629
- Phases
- PHASE2
- Conditions
Oral Cavity Neoplasm, Oropharyngeal Neoplasm, Stage 0 Oral Cavity Squamous Cell Carcinoma American Joint Committee on Cancer (AJCC) v6 and v7, Stage 0 Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage I Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage II Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet, Pharmacological Study, Placebo
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-03-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02917629?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
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