Trial Outcomes & Findings for Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD (NCT NCT02680756)

Last Updated: 2020-11-02

Results Overview

Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women,\>=13g/dL men) at Week 12

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

250 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2020-11-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Oral Ferric Iron Compound 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron Administered as per the local SmPC/PI Ferric Carboxymaltose
Overall Study STARTED	125	125
Overall Study Received Treatment	127	120
Overall Study COMPLETED	93	106
Overall Study NOT COMPLETED	32	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Ferric Iron Compound 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron Administered as per the local SmPC/PI Ferric Carboxymaltose
Overall Study Adverse Event	10	2
Overall Study Lost to Follow-up	7	6
Overall Study Withdrawal by Subject	5	5
Overall Study Physician Decision	4	1
Overall Study Hb ≤7.5 g/dL	0	2
Overall Study Blood transfusion for any reason	0	1
Overall Study Death	1	0
Overall Study Protocol Violation	1	0
Overall Study TSAT above 60% or a ferritin above 800 m	1	0
Overall Study None of above or not recorded	3	2

Baseline Characteristics

This baseline measure is applicable to the female population only.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose	Total n=250 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 14.58 • n=125 Participants	40.4 years STANDARD_DEVIATION 15.54 • n=125 Participants	40.2 years STANDARD_DEVIATION 15.04 • n=250 Participants
Age, Customized Age range	40.0 years n=125 Participants	40.4 years n=125 Participants	40.2 years n=250 Participants
Sex: Female, Male Female	68 Participants n=125 Participants	77 Participants n=125 Participants	145 Participants n=250 Participants
Sex: Female, Male Male	57 Participants n=125 Participants	48 Participants n=125 Participants	105 Participants n=250 Participants
Race/Ethnicity, Customized Race · American Indian/Alaskan Native	0 Participants n=125 Participants	1 Participants n=125 Participants	1 Participants n=250 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=125 Participants	2 Participants n=125 Participants	2 Participants n=250 Participants
Race/Ethnicity, Customized Race · Black/African American	6 Participants n=125 Participants	3 Participants n=125 Participants	9 Participants n=250 Participants
Race/Ethnicity, Customized Race · White	110 Participants n=125 Participants	111 Participants n=125 Participants	221 Participants n=250 Participants
Race/Ethnicity, Customized Race · Other	8 Participants n=125 Participants	8 Participants n=125 Participants	16 Participants n=250 Participants
Race/Ethnicity, Customized Race · Native American/Pacific Islander	1 Participants n=125 Participants	0 Participants n=125 Participants	1 Participants n=250 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	15 Participants n=125 Participants	20 Participants n=125 Participants	35 Participants n=250 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	99 Participants n=125 Participants	94 Participants n=125 Participants	193 Participants n=250 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	8 Participants n=125 Participants	8 Participants n=125 Participants	16 Participants n=250 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	3 Participants n=125 Participants	3 Participants n=125 Participants	6 Participants n=250 Participants
Fertility status (females) Sterile	8 Participants n=68 Participants • This baseline measure is applicable to the female population only.	6 Participants n=77 Participants • This baseline measure is applicable to the female population only.	14 Participants n=145 Participants • This baseline measure is applicable to the female population only.
Fertility status (females) Post-menopausal	13 Participants n=68 Participants • This baseline measure is applicable to the female population only.	16 Participants n=77 Participants • This baseline measure is applicable to the female population only.	29 Participants n=145 Participants • This baseline measure is applicable to the female population only.
Fertility status (females) Potentially fertile	46 Participants n=68 Participants • This baseline measure is applicable to the female population only.	54 Participants n=77 Participants • This baseline measure is applicable to the female population only.	100 Participants n=145 Participants • This baseline measure is applicable to the female population only.
Fertility status (females) Not available	1 Participants n=68 Participants • This baseline measure is applicable to the female population only.	1 Participants n=77 Participants • This baseline measure is applicable to the female population only.	2 Participants n=145 Participants • This baseline measure is applicable to the female population only.
Screening Hb for randomisation <10 g/dL Female or <11 g/dL Male	67 Participants n=125 Participants	67 Participants n=125 Participants	134 Participants n=250 Participants
Screening Hb for randomisation ≥10 g/dL Female or ≥11 g/dL Male	58 Participants n=125 Participants	58 Participants n=125 Participants	116 Participants n=250 Participants
Baseline Hb <9.5 g/dL	38 Participants n=125 Participants	35 Participants n=125 Participants	73 Participants n=250 Participants
Baseline Hb ≥9.5 g/dL	87 Participants n=125 Participants	90 Participants n=125 Participants	177 Participants n=250 Participants
IBD subgroup Crohn's disease	79 Participants n=125 Participants	79 Participants n=125 Participants	158 Participants n=250 Participants
IBD subgroup Ulcerative colitis	46 Participants n=125 Participants	46 Participants n=125 Participants	92 Participants n=250 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women,\>=13g/dL men) at Week 12

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 Responder	84 Participants	105 Participants
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 Non-responder	41 Participants	20 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: re-evaluated PP

Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women, \>=13g/dL men) at Week 12

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=78 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=88 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 Responder	53 Participants	75 Participants
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 Non-responder	25 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Change in hemoglobin concentration from baseline to Week 12.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Change in Hb Concentration From Baseline to Week 12	2.45 g/dL Standard Deviation 1.449	3.04 g/dL Standard Deviation 1.576

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \<9.5 g/dL.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=38 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=35 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL	2.83 g/dL Standard Deviation 1.493	4.18 g/dL Standard Deviation 1.686

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 Responder	107 Participants	111 Participants
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 Non-responder	18 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI) Not all subjects were tested.

Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=38 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=35 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 Responder	35 Participants	32 Participants
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 Non-responder	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men)

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Hb Concentration Within Normal Limits at Week 12 Responder	69 Participants	101 Participants
Number of Subjects With Hb Concentration Within Normal Limits at Week 12 Non-responder	56 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men)

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=38 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=35 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 Responder	12 Participants	28 Participants
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 Non-responder	26 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: ITT (OC) Not all subjects were tested.

Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: \>=12g/dL women, \>=13g/dL men)

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months week 24 · Non-anaemic	52 Participants	58 Participants
Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months week 24 · Anaemic	28 Participants	27 Participants
Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months week 52 · Non-anaemic	37 Participants	36 Participants
Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months week 52 · Anaemic	24 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Change in hemoglobin concentration from baseline to Week 4.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Change in Hb Concentration From Baseline to Week 4	1.27 g/dL Standard Deviation 0.974	2.19 g/dL Standard Deviation 1.133

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \<9.5 g/dL.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=38 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=35 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL	1.35 g/dl Standard Deviation 0.993	2.99 g/dl Standard Deviation 1.092

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 Responder	76 Participants	96 Participants
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 Non-responder	49 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT (MI)

Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=38 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=35 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12 Responder	26 Participants	30 Participants
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12 Non-responder	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 Responder	75 Participants	105 Participants
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 Non-responder	50 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=36 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=33 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 Responder	22 Participants	31 Participants
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 Non-responder	14 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Hb Concentration Within Normal Limits at Week 4 Responder	31 Participants	60 Participants
Number of Subjects With Hb Concentration Within Normal Limits at Week 4 Non-responder	94 Participants	65 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=38 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=35 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 Responder	2 Participants	15 Participants
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 Non-responder	36 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 Responder	26 Participants	75 Participants
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 Non-responder	99 Participants	50 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITT (MI)

Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=38 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=35 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 Responder	5 Participants	28 Participants
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 Non-responder	33 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52 (LOCF)

Population: ITT

A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research \& general population surveys. The SF-36 includes one multi-item scale that assesses 8 health components: Physical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; \& General Health Component. These 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score \& the Physical Component Score where higher values mean a better outcome. Both scales range from 0 to 100, where higher scores indicate better health status. The survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language.

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=125 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=125 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Change From Baseline Physical Component and Mental Component Score Physical component score	3.0 score on a scale Standard Deviation 7.62	2.5 score on a scale Standard Deviation 7.52
Change From Baseline Physical Component and Mental Component Score Mental component score	3.3 score on a scale Standard Deviation 8.32	2.6 score on a scale Standard Deviation 7.60

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Population: 3 subjects were randomised to IV iron but were given ferric maltol in error.

Number of Patients with Treatment-emergent Adverse Events (AEs).

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=127 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=120 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Patients With Treatment-emergent Adverse Events (AEs)	75 Participants	43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Population: 3 subjects were randomised to IV iron but were given ferric maltol in error.

Number of Patients with Treatment-emergent Serious Adverse Events (SAEs).

Outcome measures

Outcome measures
Measure	Oral Ferric Iron Compound n=127 Participants 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=120 Participants Administered as per the local SmPC/PI Ferric Carboxymaltose
Number of Patients With Treatment-emergent Serious Adverse Events (SAEs)	9 Participants	3 Participants

Adverse Events

Oral Ferric Iron Compound

Serious events: 12 serious events

Other events: 75 other events

Deaths: 1 deaths

Intravenous Iron

Serious events: 4 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Ferric Iron Compound n=127 participants at risk 30 mg capsules to be taken orally twice a day Ferric Maltol	Intravenous Iron n=120 participants at risk Administered as per the local SmPC/PI Ferric Carboxymaltose
Gastrointestinal disorders Gastrointestinal disorders	2.4% 3/127 • Number of events 3 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	1.7% 2/120 • Number of events 4 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.
Infections and infestations Infections and infestations	2.4% 3/127 • Number of events 5 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	0.83% 1/120 • Number of events 1 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	1.6% 2/127 • Number of events 3 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	0.00% 0/120 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.
Cardiac disorders Cardiac disorders	1.6% 2/127 • Number of events 2 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	0.00% 0/120 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.79% 1/127 • Number of events 1 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	0.00% 0/120 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.
General disorders General disorders and administration site conditions	0.79% 1/127 • Number of events 1 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	0.00% 0/120 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.00% 0/127 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	0.83% 1/120 • Number of events 1 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.
Psychiatric disorders Psychiatric disorders	0.79% 1/127 • Number of events 1 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.	0.00% 0/120 • The analysis of AEs focuses on TEAEs, which were defined as any AE that occurred on or worsened after the first dose of IMP and up to 14 days after the last dose of IMP (week 52 if study completed) The figures provided won't equal the total number of participants as several patients may have had the same AE. 250 patients were randomised: 125 pts in the ferric maltol group \& in the IV iron group each. Of these, 247 pts received at least 1 dose of IMP \& were included in the safety analysis. 2 pts randomised to IV were not treated: 1 pt was randomised in error \& was withdrawn, 1 pt withdrew consent; 1 pt randomised to FM was not treated \& lost to follow-up; 3 pts were given FM instead of IV.

Other adverse events

Additional Information

Jackie Mitchell MA DPhil

Shield Therapeutics

Phone: 0044 752 565 6885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place