Comparison · NCT04935879-sae
Inclacumab 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. Inclacumab vs Placebo: serious adverse events. Trial comparisons, record NCT04935879-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04935879-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 | 0.195 | 0.134 | 0.276 | wilson | |
| Risk in group 2 | 0.223 | 0.158 | 0.305 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0282 | -0.131 | 0.0753 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.874 | 0.532 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 0.843 | 0.451 | 1.57 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Inclacumab than on Placebo | 35.4 | 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 | Inclacumab | Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of 48-Week Treatment Period. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60. | 23 | 118 | EG000 |
| Group 2 | Placebo | Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of 48-Week Treatment Period. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60. | 27 | 121 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to Week 60 (12 week of follow-up post Week 48)
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
- NCT number
- NCT04935879
- Phases
- PHASE3
- Conditions
- Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
- Interventions
- Inclacumab, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2025-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04935879?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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