Comparison · NCT04218084-sae
Voxelotor vs 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. Voxelotor vs Placebo: serious adverse events. Trial comparisons, record NCT04218084-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04218084-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 | 0.525 | 0.436 | 0.612 | wilson | |
| Risk in group 2 | 0.371 | 0.288 | 0.461 | wilson | |
| Risk difference, group 1 minus group 2 | 0.154 | 0.0274 | 0.274 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.42 | 1.06 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 1.88 | 1.12 | 3.16 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Voxelotor than on Placebo | 6.48 | 3.65 | 36.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Voxelotor | Participants aged greater than or equal to 12 years and less than 15 years of age were to receive 1500 mg voxelotor tablet orally once daily for 96 weeks or study termination, whichever occurred first. Participants less than 12 years of age received voxelotor at a weight based (1500 mg-equivalent) dose. Participants were followed up to 4 weeks after the last dose of study drug. | 63 | 120 | EG000 |
| Group 2 | Placebo | Participants were to receive voxelotor matched placebo orally once daily for 96 weeks or study termination, whichever occurred first. Participants were followed up to 4 weeks after the last dose of study drug. | 43 | 116 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization to the last dose date, post-randomization HU initiation with no HU at baseline, end of study or study termination, whichever occurred earlier (maximum up to 110 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease
- NCT number
- NCT04218084
- Phases
- PHASE3
- Conditions
- Sickle Cell Disease
- Interventions
- Voxelotor, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2025-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04218084?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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