Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions

Documents

Study protocol

Initial protocol

IV_Iron_PASS_AmendedProtocol_v1.1_04May2017_Redacted

Updated protocol

IVfePASS_Protocol_V2.1_FINAL_26September2019_Redacted_ok

First published: 22/02/2024

Study results

Study results

IV Iron PASS_Abstract_results_Redacted

IV Iron PASS_Final Report_Revised V1.3_20Nov2020_Redacted

Study report

Other information

Study, other information

Annex5_DoIForm_EUPASnumber__Update11Feb2020

Annex5_DOI_SAB_ABircher

IV Iron_DoIForms_2_2

IV Iron_DoIForms_2_2_update_5Feb2019

IV Iron_DoIForms_3_3

IV-IRON_DOI CDP-20190207

NewDoI_updated_5Feb2019

Publications

Study publications

Fortuny J, von Gersdorff G, Lassalle R, Linder M, Overbeek J, Reinold J, Toft G…

de Sordi D, Kappen S, Otto‐Sobotka F, Kulschewski A, Weyland A, Gutierrez L, Fo…

Gutierrez L, Bezemer ID, Dress J, Ehrenstein V, Forstner M, Franzoni C, Lassall…

Gutierrez L, Blin P, Dress J, Droz-Perroteau C, Ehrenstein V, Franzoni C, Kollh…

ENCePP Seal

The use of the ENCePP Seal has been discontinued since February 2025. The ENCePP Seal fields are retained in the display mode for transparency but are no longer maintained.

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

IV Iron_DoIForms_1_2

IV Iron_DoIForms_1_2_update_5Feb2019

Composition of steering group and observers

IV Iron Steering Committee

Steering Committee List_2019

Signed code of conduct

2017-0046_Declaration_EUPAS20720

Signed code of conduct checklist

2017-0046_Checklist_EUPAS20720

Signed checklist for study protocols

2017-0046_Checklist for Study Protocols_EUPAS20720