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Comparison · NCT02269943-sae

CC-486 200 mg vs CC-486 300 mg: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. CC-486 200 mg vs CC-486 300 mg: serious adverse events. Trial comparisons, record NCT02269943-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02269943-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6670.30.903wilson
Risk in group 20.40.2460.577wilson
Risk difference, group 1 minus group 20.267-0.140.549newcombe hybrid score
Risk ratio, group 1 over group 21.670.8153.41log
Odds ratio, group 1 over group 230.47319log
Number needed to harm, for one more participant with a serious adverse event on CC-486 200 mg than on CC-486 300 mg3.75from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1CC-486 200 mg
Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle.
46EG000
Group 2CC-486 300 mg
Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death.
1230EG001

Harm

What it counts
Total, serious adverse events
Time frame
From Day 1 of study treatment until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter that are suspected of being related to IP; up to final cut-off date of 08 August 2017; median duration of study treatment was 257 days for CC-486 200 mg and 114.5 days for CC-486 300 mg.

Source ClinicalTrials.gov

Trial

Title
Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
NCT number
NCT02269943
Phases
PHASE2
Conditions
Nasopharyngeal Neoplasms
Interventions
CC-486
Lead sponsor
Celgene
Results first posted
2018-06-01

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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