This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD (NCT02680756), a randomized phase 3 study. The primary outcome is Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02680756 |
| Phase | Phase 3 |
| Condition | Anemia, Iron-Deficiency, Inflammatory Bowel Disease, Crohn's Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 250 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Shield Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
People with iron deficiency anaemia and inflammatory bowel disease were eligible for the clinical question addressed. The registry lists iron-deficiency anaemia, inflammatory bowel disease and Crohn's disease as conditions. The primary endpoint population is described as ITT (MI); the registry does not explain that label further.
Intervention
The intervention was oral ferric maltol: 30 mg capsules taken twice a day for 52 weeks. The record describes it as an oral ferric iron compound.
Comparator
The comparison was intravenous iron, specifically ferric carboxy maltose. Its administration was according to the local summary of product characteristics.
Primary question
At Week 12, how many participants achieved either a 2 g/dL increase in haemoglobin or normalization of haemoglobin, defined as at least 12 g/dL for women and at least 13 g/dL for men? The registry describes the endpoint and analysis population, but the primary endpoint results are not reported in the registry record.
This is a comparison of two routes and preparations of iron treatment in the context of inflammatory bowel disease. The primary outcome combines two ways of meeting a haemoglobin target: an increase from baseline or reaching the stated normal-range threshold. A participant can meet the composite through either route. Consequently, the composite result alone would not reveal how many met the increase criterion, how many reached the normal-range criterion, or how much the groups differed on each component separately.
The study also planned to assess several other haemoglobin outcomes, including change from baseline at Week 12 and Week 4, outcomes among participants with lower baseline haemoglobin, and whether participants were non-anaemic at later time points. The registry lists these as secondary outcomes. Results for those outcomes are not reported in the registry record.
3. Trial Design
The registry describes a Phase 3b, randomized, controlled, multicentre study with a parallel-group design and no masking. It lists an enrollment of 250 and a completed study. The recorded start was 2016-01, and primary completion was 2018-10. Shield Therapeutics is listed as sponsor.
Participants were assigned to oral ferric maltol or intravenous ferric carboxy maltose. The oral regimen was 30 mg capsules twice a day for 52 weeks. Intravenous iron was administered according to the local summary of product characteristics; a more detailed schedule is not reported in the registry record. Because masking was listed as none, the trial was open-label. The registry does not report further details about sequence generation, allocation concealment, or how assignment was implemented.
The primary endpoint was assessed from baseline to Week 12. It counted participants who achieved either a 2 g/dL increase in haemoglobin or normalization, using sex-specific thresholds of at least 12 g/dL for women and at least 13 g/dL for men. The specified analysis population is ITT (MI), a label whose expansion and implementation are not reported in the registry record.
Listed secondary outcomes include haemoglobin change at Week 12, haemoglobin change in the baseline subgroup below 9.5 g/dL, and the number achieving an increase of at least 1 g/dL at Week 12. Other listed outcomes concern normal haemoglobin at Week 12, being non-anaemic at 6 months and 12 months, and haemoglobin change at Week 4. The registry lists 22 outcome measures and 2 analyses, but the analysis details and results are not reported in the registry record.
The registry also records safety events for both groups. The specific serious-event counts and other-event counts are described separately. The available information does not establish whether every participant completed the planned treatment period or how adherence, treatment discontinuation, or follow-up were handled.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 462 subjects were screened; of these, 212 subjects were not randomised (202 screening failures and 10 not assigned). 250 subjects (54% of the screened population) were randomised: 125 subjects to the ferric maltol group and 125 subjects to the IV iron group.
Overall Study
| Stage | Oral Ferric Iron Compound | Intravenous Iron |
|---|---|---|
| STARTED | 125 | 125 |
| Received Treatment | 127 | 120 |
| COMPLETED | 93 | 106 |
| NOT COMPLETED | 32 | 19 |
Reasons for not completing this period:
| Reason | Oral Ferric Iron Compound | Intravenous Iron |
|---|---|---|
| Adverse Event | 10 | 2 |
| Lost to Follow-up | 7 | 6 |
| Withdrawal by Subject | 5 | 5 |
| Physician Decision | 4 | 1 |
| Hb ≤7.5 g/dL | 0 | 2 |
| Blood transfusion for any reason | 0 | 1 |
| Death | 1 | 0 |
| Protocol Violation | 1 | 0 |
| TSAT above 60% or a ferritin above 800 m | 1 | 0 |
| None of above or not recorded | 3 | 2 |
Analysis population for the primary outcome, as defined in the registry: ITT (MI)
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: ITT
| Characteristic | Unit | Oral Ferric Iron Compound | Intravenous Iron | Total |
|---|---|---|---|---|
| Participants analysed | 125 | 125 | 250 | |
| Age, Continuous | years | 40.0 (SD 14.58) | 40.4 (SD 15.54) | 40.2 (SD 15.04) |
| Age, Customized: Age range | years | 40.0 (18 to 81) | 40.4 (19 to 77) | 40.2 (18 to 81) |
| Sex: Female, Male: Female | Participants | 68 | 77 | 145 |
| Sex: Female, Male: Male | Participants | 57 | 48 | 105 |
| Race/Ethnicity, Customized: Race – American Indian/Alaskan Native | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Race – Asian | Participants | 0 | 2 | 2 |
| Race/Ethnicity, Customized: Race – Black/African American | Participants | 6 | 3 | 9 |
| Race/Ethnicity, Customized: Race – White | Participants | 110 | 111 | 221 |
| Race/Ethnicity, Customized: Race – Other | Participants | 8 | 8 | 16 |
| Race/Ethnicity, Customized: Race – Native American/Pacific Islander | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Ethnicity – Hispanic or Latino | Participants | 15 | 20 | 35 |
| Race/Ethnicity, Customized: Ethnicity – Not Hispanic or Latino | Participants | 99 | 94 | 193 |
| Race/Ethnicity, Customized: Ethnicity – Not Reported | Participants | 8 | 8 | 16 |
| Race/Ethnicity, Customized: Ethnicity – Unknown | Participants | 3 | 3 | 6 |
| Fertility status (females): Sterile | Participants | 8 | 6 | 14 |
| Fertility status (females): Post-menopausal | Participants | 13 | 16 | 29 |
| Fertility status (females): Potentially fertile | Participants | 46 | 54 | 100 |
| Fertility status (females): Not available | Participants | 1 | 1 | 2 |
| Screening Hb for randomisation: <10 g/dL Female or <11 g/dL Male | Participants | 67 | 67 | 134 |
| Screening Hb for randomisation: ≥10 g/dL Female or ≥11 g/dL Male | Participants | 58 | 58 | 116 |
| Baseline Hb: <9.5 g/dL | Participants | 38 | 35 | 73 |
| Baseline Hb: ≥9.5 g/dL | Participants | 87 | 90 | 177 |
| IBD subgroup: Crohn's disease | Participants | 79 | 79 | 158 |
| IBD subgroup: Ulcerative colitis | Participants | 46 | 46 | 92 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12, measured over Baseline to Week 12.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants who met either of two haemoglobin criteria by Week 12: an increase of 2 g/dL from baseline or haemoglobin normalization. Normalization is defined as at least 12 g/dL for women and at least 13 g/dL for men. The registry describes the endpoint as a count of participants, assessed from baseline to Week 12, in an ITT (MI) population.
As a general statistical concept, a composite endpoint can capture more than one clinically relevant way of reaching a target in a single outcome. Here, a participant qualifies by meeting either criterion. This can make the endpoint broader than a measure of haemoglobin change alone, but it also means the combined count does not show which criterion drove the result. Separate component results would be needed to understand the contributions of haemoglobin increase and normalization.
The endpoint is used to summarize whether participants met a prespecified haemoglobin response definition by a particular follow-up time. The registry does not report the number meeting the composite in either group, a comparison between groups, or a confidence interval. It therefore does not support a numerical conclusion about the relative primary endpoint results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and the definition of its primary endpoint, but it does not report the primary outcome counts or a treatment comparison. The number of participants who met the composite endpoint in either group, the estimated difference between groups, and the precision of that comparison are not reported in the registry record. The primary outcome is also listed among the items excluded from reduction to a single comparison because it has several categories or time points. Accordingly, no numerical estimate of the primary treatment contrast can be described from this record.
This absence is important for interpretation. The trial's enrollment is recorded as 250, but enrollment alone does not indicate how many participants contributed data to the Week 12 endpoint or how many met its criteria. It should not be treated as a substitute for an outcome count or an analysis denominator. The safety denominators are reported separately and should not be assumed to be the endpoint analysis denominators.
The endpoint is a composite: meeting either the specified haemoglobin increase or the sex-specific normalization threshold counts as success. If a composite result were available, its interpretation would depend on both components. A combined count would not by itself show whether changes in the two groups were driven by increased haemoglobin, normalization, or both. Component-specific results are not reported in the registry record.
The study was randomized, which is a design feature intended to support comparisons between assigned groups. It was also unmasked, so participants and study personnel were not blinded according to the registry. The record does not report how outcome assessment was conducted or whether knowledge of treatment assignment could have influenced measurement or other trial procedures. No claim about the direction or size of any such influence can be made from the available information.
The secondary outcomes provide a broader planned view of haemoglobin response, including change at different time points, outcomes for participants with baseline haemoglobin below 9.5 g/dL, and later non-anaemia status. The registry lists these outcomes but does not report their results. Thus, the record does not support conclusions about the consistency of response across time points or subgroups.
Safety counts are available for serious adverse events, other adverse events and deaths. Those counts describe recorded events in the groups, but without further detail they do not establish cause, severity distribution beyond the serious-event classification, or whether events were judged related to treatment. They also do not answer the efficacy question. Overall, the registry supports a description of the design and outcome definitions, alongside a limited account of safety counts, but not a quantitative interpretation of the primary efficacy comparison.
9. Statistical Methods Explained
Randomized parallel-group trials compare outcomes in groups assigned to different interventions. Random assignment is intended to make the groups comparable on average at the outset, including with respect to factors that may affect the outcome. It does not guarantee that the groups will be identical in every respect. The registry identifies this study as randomized and parallel-group, but details of sequence generation and allocation concealment are not reported in the registry record.
What does the primary endpoint count?
The primary endpoint is a binary participant-level outcome: each participant either meets the composite definition by Week 12 or does not. The definition combines a haemoglobin increase of 2 g/dL with normalization at the specified sex-specific thresholds. Although the registry expresses the endpoint as a count, comparative analysis would generally need the count and the relevant analysis denominator for each group. Those primary outcome values are not reported in the registry record, so no group proportion or contrast can be stated.
As a general statistical concept, binary outcomes are often compared by estimating a difference in proportions, a ratio of proportions, or another prespecified contrast. These estimates answer different questions and have different interpretations. The registry does not report which contrast was planned or the corresponding estimate, so it is not possible to identify or interpret a primary effect measure for this study.
What does precision mean?
As a general explanation, a confidence interval describes a range of values compatible with the observed data under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval; an interval spanning a broad range leaves more uncertainty about the size and direction of the effect. A confidence interval is not reported for the primary endpoint in the registry record. Without the estimate and its interval, the precision of the primary comparison cannot be assessed.
A p-value, when reported, addresses how compatible data are with a specified statistical null hypothesis under the analysis assumptions. It is not a measure of effect size, clinical importance, or the probability that a treatment is effective. No primary endpoint p-value is reported in the registry record. Nor is a statistical model, significance threshold, or adjustment approach for the primary comparison described there.
Why can a composite need careful reading?
As a general concept, a composite combines multiple events or criteria into one outcome. That can provide a single summary, but components can differ in frequency and meaning. The composite allows either a specified increase or normalization to qualify. The combined outcome would not show component-level results unless those are reported separately. The registry does not report those component counts.
The endpoint is defined at Week 12, but the record also lists other haemoglobin outcomes at Week 4, Week 12, 6 months and 12 months. Looking across several endpoints or time points can raise multiplicity concerns: the more comparisons examined, the greater the opportunity for apparently notable results to arise by chance when no adjustment is made. This is a general statistical consideration, not a statement about the analysis used in this trial. The registry record does not report a multiplicity strategy or clarify which secondary comparisons, if any, were confirmatory.
How should missing data be considered?
Missing outcome values can affect a group comparison, particularly if missingness differs between groups or is related to participants' outcomes. Analyses may address missing values using different assumptions and methods; each approach can influence the estimate and its uncertainty. The primary population is labeled ITT (MI), but the registry does not explain the abbreviation or report the missing-data procedure, assumptions, or sensitivity analyses. The label alone is not enough to establish how missing Week 12 measurements were treated.
In general, an intention-to-treat approach seeks to analyze participants according to their randomized group, but implementation details matter when outcomes are missing or participants stop treatment. The registry does not report the analysis denominator by group, participant flow, discontinuations, adherence, or whether all randomized participants were included in the primary analysis. Those details are necessary to assess how closely the analysis followed the randomized assignment and how missing data may affect interpretation.
What can planning calculations tell readers?
As a general explanation, sample-size calculations are planning tools based on assumptions about an effect, variability, allocation and statistical criteria. They are not observed trial outcomes and do not establish the precision of a completed trial's result. The stated planning assumptions for illustrations are a two-sided significance level of 0.05, equal allocation between groups, a normal approximation, and an effect set as a fraction of the observed effect. These are described as illustrations, not as the trial's own design. The registry does not report the trial's sample-size justification or enough primary outcome results to interpret an observed effect-based planning illustration. Such calculations should not be called observed power.
The registry record also does not report a full statistical analysis plan, interim analyses, subgroup analysis methods, or adjustment for covariates. These omissions limit the ability to reconstruct the intended analysis or judge whether all analyses were conducted as planned. They do not establish that a particular method was or was not used; those details are simply not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The study record lists multiple secondary outcomes covering haemoglobin change, threshold attainment, baseline haemoglobin subgroups, and later non-anaemia status. Examining several outcomes or time points creates a general multiplicity issue: without an appropriate strategy, the chance of at least one apparently unusual finding can increase across repeated comparisons. The registry record does not report whether outcomes were hierarchically ordered, whether statistical tests were adjusted, or how the primary and secondary outcomes were distinguished for confirmatory interpretation.
Missing outcome data also require attention. The primary population is labeled ITT (MI), but the meaning and implementation of that label are not reported in the registry record. The record does not describe how missing Week 12 haemoglobin values were handled, the assumptions used for any missing-data method, or whether sensitivity analyses were performed. It also does not report group-specific analysis denominators or participant flow for the primary endpoint. Enrollment of 250 does not establish the number contributing to that analysis.
The record identifies the primary outcome as a count of participants meeting a composite definition, but the results are not reported. It therefore does not provide the event counts, denominator, treatment comparison, or uncertainty needed to evaluate that endpoint. Details of the statistical analysis plan, including the planned effect measure, significance threshold, and any multiplicity or missing-data procedures, are not reported in the registry record. These gaps limit assessment of both the analysis and the robustness of any efficacy interpretation.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Oral Ferric Iron Compound | 12 | 127 | 9.4% |
| Intravenous Iron | 4 | 120 | 3.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Oral Ferric Iron Compound | 1 of 127 |
| Intravenous Iron | 0 of 120 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Oral Ferric Iron Compound | 75 of 127 |
| Intravenous Iron | 43 of 120 |
Most frequent serious adverse event terms
| Event term | Organ system | Oral Ferric Iron Compound | Intravenous Iron |
|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | 3 of 127 | 2 of 120 |
| Infections and infestations | Infections and infestations | 3 of 127 | 1 of 120 |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | 2 of 127 | 0 of 120 |
| Cardiac disorders | Cardiac disorders | 2 of 127 | 0 of 120 |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | 1 of 127 | 0 of 120 |
| General disorders and administration site conditions | General disorders | 1 of 127 | 0 of 120 |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 127 | 1 of 120 |
| Psychiatric disorders | Psychiatric disorders | 1 of 127 | 0 of 120 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Oral Ferric Iron Compound | Intravenous Iron |
|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | 40 of 127 | 15 of 120 |
| Infections and infestations | Infections and infestations | 29 of 127 | 22 of 120 |
| Abdominal pain | General disorders | 12 of 127 | 15 of 120 |
| General disorders and administration site conditions | General disorders | 9 of 127 | 6 of 120 |
| Nasopharyngitis | Infections and infestations | 10 of 127 | 4 of 120 |
| Nervous system disorders | Nervous system disorders | 9 of 127 | 4 of 120 |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | 9 of 127 | 4 of 120 |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | 11 of 127 | 2 of 120 |
| Abdominal pain upper | Gastrointestinal disorders | 7 of 127 | 2 of 120 |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | 7 of 127 | 2 of 120 |
Serious events with the highest arm-level rate: gastrointestinal disorders (2.4%), infections and infestations (2.4%), injury, poisoning and procedural complications (1.6%), cardiac disorders (1.6%), neoplasms benign, malignant and unspecified (0.8%).
The registry reports serious adverse events for the oral ferric iron compound group as 12 participants with events among 127 at risk, and for the intravenous iron group as 4 participants with events among 120 at risk. It reports other adverse events for 75 participants among 127 at risk in the oral group and 43 among 120 at risk in the intravenous group. Deaths are reported as 1 in the oral group and 0 in the intravenous group.
These are counts of participants with recorded events, not estimates of a causal treatment effect. The registry information does not describe event timing, duration, recurrence, seriousness criteria, relatedness to treatment, or how participants with multiple events were handled. The serious-event terms listed include gastrointestinal disorders and infections and infestations at 2.4% each; injury, poisoning and procedural complications and cardiac disorders at 1.6% each; and neoplasms and blood and lymphatic system disorders at 0.8% each. The record does not specify a group-specific denominator for these listed percentages.
Differences in observed counts should not be interpreted as proof that one treatment caused more or fewer events. The safety figures do not include a reported comparative estimate or uncertainty interval, and the available record does not provide enough context to assess event attribution or exposure time.
12. What the Result Does, and Does Not, Mean
The registry record supports a clear description of the trial's intended comparison: oral ferric maltol versus intravenous ferric carboxy maltose in people with iron deficiency anaemia and inflammatory bowel disease. It also gives the primary haemoglobin response definition, its Week 12 timeframe, and the named analysis population. Those details explain what the trial was designed to ask, but they do not supply the primary outcome result.
Because the primary endpoint counts participants who meet either of two criteria, a reported composite result would summarize response under that combined definition. It would not, by itself, establish the separate results for haemoglobin increase and normalization. Nor would it describe the size of change for each participant. Component-level data and appropriate between-group estimates would be needed for those interpretations.
The absence of the primary outcome counts and comparison means the registry record does not establish which group had a larger response, how large any difference was, or how precise an estimate might be. It also does not permit a conclusion that the treatments were equivalent or different. A non-reported result is not evidence of no effect; it is a limit on what can be inferred from this record.
The safety counts provide descriptive information about serious adverse events, other adverse events and deaths, but do not establish that events were caused by either treatment. Interpretation would require additional context, including event definitions, attribution, timing and follow-up. The record also lists multiple secondary outcomes without reporting their results, so it cannot show whether findings were consistent across outcomes or time points.
In short, the registry describes a randomized, unmasked comparison and a defined primary endpoint, but it does not report the endpoint's results or the statistical analysis needed to quantify the efficacy comparison. Conclusions should remain within those limits.
13. Why This Trial Matters Statistically
This trial addresses a statistical question that is common in clinical research: how to compare two assigned interventions using a threshold-based outcome measured after treatment. Its primary endpoint combines an increase in haemoglobin with reaching a normal-range threshold. That makes the definition and interpretation of the composite important, because the combined result can conceal different patterns across its components.
The randomized, parallel-group design is relevant because it offers a framework for comparing groups assigned to different treatments. The open-label status also matters when considering how outcomes and trial conduct might be affected by knowledge of treatment assignment. The registry does not provide enough detail to determine whether that influenced outcome assessment or other processes.
Statistically, the record illustrates why an outcome definition and study design are not a substitute for reporting results. Without group-specific primary outcome counts, denominators, an effect estimate and an uncertainty interval, readers cannot assess the magnitude or precision of the comparison. Enrollment alone cannot fill that gap.
The numerous listed secondary outcomes also underscore the value of a clearly described analysis plan. Multiple outcomes, time points and subgroups can require a prespecified approach to interpretation. The registry record does not report that approach, or the results for those secondary outcomes. The available safety counts add descriptive context, but cannot answer the efficacy question or establish causation.
For biostatisticians and clinical researchers, the record therefore highlights the distinction between a trial's stated aims and the evidence needed to evaluate its findings. Clear outcome definitions, denominators, analysis methods, missing-data procedures, and estimates with measures of precision are all important for a transparent quantitative interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for statistical interpretation is that the registry record does not report the primary endpoint results. It gives no group-specific count of participants meeting the composite, no analysis denominators, and no treatment-effect estimate or confidence interval. As a result, the primary comparison cannot be quantified from this record.
The primary endpoint is composite, so even a combined result would not identify the separate contribution of haemoglobin increase and normalization without component-level results. The registry also lists secondary outcomes across time points and subgroups but does not report their findings. It does not state how those analyses were prioritized or whether multiplicity was addressed.
The study is identified as unmasked, but the record does not describe outcome assessment procedures or whether assessors were independent of treatment assignment. It does not report randomization implementation, allocation concealment, participant flow, discontinuations, adherence, or group-specific follow-up for the primary outcome. These details are relevant to assessing how the planned comparison was carried out.
The primary analysis population is labeled ITT (MI), but the record does not explain the label, how missing observations were handled, or what assumptions informed the analysis. No sensitivity analyses are described. The safety information is also limited: it gives participant counts and selected serious-event terms but not event timing, attribution, exposure-adjusted comparisons, or detailed definitions.
Finally, the sample-size justification, full statistical analysis plan, interim analyses, and detailed statistical methods are not reported in the registry record. These limitations do not show that particular procedures were omitted; they mean the record does not permit their assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD — NCT02680756.
- Registry record last updated 2020-11-02; status last verified 2020-10.
- Results first posted 2020-02-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed, randomized, controlled, multicentre, open-label, parallel-group Phase 3b trial sponsored by Shield Therapeutics. It records enrollment of 250, a start in 2016-01 and primary completion in 2018-10. The comparison was oral ferric maltol, given as 30 mg twice a day for 52 weeks, versus intravenous ferric carboxy maltose administered according to the local summary of product characteristics.
The primary outcome counted participants achieving either a 2 g/dL haemoglobin increase or normalization by Week 12, using thresholds of at least 12 g/dL for women and at least 13 g/dL for men. The analysis population is labeled ITT (MI). The primary endpoint results, its comparative estimate and its precision are not reported in the registry record.
The record lists 22 outcome measures and 2 analyses. It also reports serious adverse events, other adverse events and deaths by group, along with selected serious-event terms. Further detail on the statistical plan, missing-data handling, participant flow, and event attribution is not reported in the registry record.