Hetzel 2013a.

Methods	Two studies, Phase III, RCTs
Participants	Patients with inflammatory bowel disease and iron deficiency (baseline haemogloblin (Hgb) < 10g/dL and > 7g/dL and transferrin saturation (TSAT) < 20%) Exclusion criteria: Not reported A total of 116 participants were included in the analysis of Study 1. Participants were randomised to the ferumoxytol group (n = 79; Study 1 n = 47), iron sucrose group (n = 25) and placebo group (n = 12). Loss to follow‐up: Not reported
Interventions	Ferumoxytol Dosing regimen: 2 injections each 510 mg, 3‐8 days apart Mode of delivery: Intravenous Duration: 5 weeks Setting: Not reported Comparision treatment: Study 1 ‐ placebo (comparator) Co‐interventions: Not reported
Outcomes	Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F) Quality of life was not assessed Adverse events (AEs) were assessed as follows: all AEs; related AEs; serious AEs; related serious AEs, AEs of special interest – protocol defined (included protocol defined signs and symptoms of hypotension and hypersensitivity); cardiovascular AE composite endpoint (included myocardial infarctions, heart failure, moderate to severe hypertension, and hospitalisation due to any cardiovascular cause); AEs resulting in study discontinuation; death Other outcomes assessed: Change in Hgb, transferrin saturation Assessment time points: Baseline, week 2, week 3, week 4, week 5
Notes	No additional information supplied by the author Study 2 (active comparator ‐ iron sucrose) excluded as fatigue not assessed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information on the methods used to generate a sequence provided
Allocation concealment (selection bias)	Unclear risk	No information on how allocation to groups occurred
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information on whether the study personnel, participant, clinical staff were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Subjective outcome but unclear if blinding occurred
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The number of participants randomised to each group and the number included in the analysis for study one was unclear. No information on the number of withdrawals and exclusion following randomisation and the reasons for this
Selective reporting (reporting bias)	High risk	Presented data on change from baseline in FACIT‐F score for the intervention group and the overall placebo population, but not the IBD placebo group
Other bias	Unclear risk	No information presented on the baseline characteristics of the interventions and placebo groups in study one or no information of the disease activity status of the participants