Comparison · NCT02940860-39e14080
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
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. Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions. Trial comparisons, record NCT02940860-39e14080. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02940860-39e14080
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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 | 0.00294 | 0.001 | 0.00862 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00753 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00294 | -0.00484 | 0.00862 | 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 treat, for one more participant with the outcome on Iron Isomaltoside/Ferric Derisomaltose than on Iron Sucrose | 340 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose, administered IV | 3 | 1,019 | OG000 |
| Group 2 | Iron Sucrose | Iron sucrose, administered IV | 0 | 506 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
- Description
Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.
- Time frame
- Baseline to week 8
- Population
- Safety analysis set. All randomised subjects who received at least one dose of the investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
- NCT number
- NCT02940860
- Phases
- PHASE3
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
- Interventions
- Iron isomaltoside/ferric derisomaltose, Iron sucrose
- Lead sponsor
- Pharmacosmos A/S
- Results first posted
- 2020-03-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02940860?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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