Trial Outcomes & Findings for A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test (NCT NCT02790437)

NCT ID: NCT02790437

Last Updated: 2021-05-20

Results Overview

IdeS ability to create a negative crossmatch (XM) test in patients who before treatment exhibit Donor Specific Antibodies (DSAs) and have a positive XM test to their available live or deceased donor kidney. XM was assessed using both FACS and CDC XM tests. FACS XM is a multi-staining procedure where the recipient's serum is used to stain donor cells to identify presence of DSAs in recipient's serum. T- and B-cells are identified using conjugated antibodies against CD3 and CD19. DSAs are identified using a conjugated anti-human antibody. CDC XM evaluates the cytotoxic capacity of the DSAs. The recipient's serum is mixed with donor cells prior to addition of complement. Fluorescent dyes are added and the live/dead cells (%) is scored using a fluorescent microscope. CDC XM amplified with anti-human globulin is not compatible with imlifidase and should not be used. The endpoint was met if at least one XM test was positive pre-dose and the last test within 24 h was negative.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: Within 24 hours of IdeS dosing
• Results posted on: 2021-05-20

Participant Flow

Participant milestones

Measure	One Dose of IdeS (0.25 mg/kg BW) One (1) IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment	Two Doses of IdeS (2 x 0.25 mg/kg BW) Two (2) IdeS intravenous infusions IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment
Overall Study STARTED	16	3
Overall Study COMPLETED	13	3
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	One Dose of IdeS (0.25 mg/kg BW) One (1) IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment	Two Doses of IdeS (2 x 0.25 mg/kg BW) Two (2) IdeS intravenous infusions IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment
Overall Study Patient graft failure - nephrectomy	1	0
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch Test

Baseline characteristics by cohort

Measure	One Dose of IdeS (0.25 mg/kg BW) n=16 Participants IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment	Two Doses of IdeS (2 x 0.25 mg/kg BW) n=3 Participants Two (2) IdeS intravenous infusions IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40 years n=5 Participants	45 years n=7 Participants	40 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Black or african american	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Indian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants	1 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Sweden	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	2 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Weight	74.05 kg n=5 Participants	68.0 kg n=7 Participants	71.6 kg n=5 Participants

PRIMARY outcome

Timeframe: Within 24 hours of IdeS dosing

Population: The full analysis set (FAS) comprises data from all patients in the safety analysis set (SAS) with available post-dose efficacy data. Before analysis it was specified that the analysis set should include all patients combined who had received the planned dose which was defined as 1 administration initially which could be repeated if needed. The single as well as the repeated administration are defined as the only planned dose. Consequently, the results are presented for all patients together.

IdeS ability to create a negative crossmatch (XM) test in patients who before treatment exhibit Donor Specific Antibodies (DSAs) and have a positive XM test to their available live or deceased donor kidney.

XM was assessed using both FACS and CDC XM tests. FACS XM is a multi-staining procedure where the recipient's serum is used to stain donor cells to identify presence of DSAs in recipient's serum. T- and B-cells are identified using conjugated antibodies against CD3 and CD19. DSAs are identified using a conjugated anti-human antibody. CDC XM evaluates the cytotoxic capacity of the DSAs. The recipient's serum is mixed with donor cells prior to addition of complement. Fluorescent dyes are added and the live/dead cells (%) is scored using a fluorescent microscope. CDC XM amplified with anti-human globulin is not compatible with imlifidase and should not be used.

The endpoint was met if at least one XM test was positive pre-dose and the last test within 24 h was negative.

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=19 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Number of Patients With Crossmatch Conversion (Positive to Negative) XM conversion within 24 h	17 Patients	—	—
Number of Patients With Crossmatch Conversion (Positive to Negative) No XM conversion within 24 h	2 Patients	—	—

SECONDARY outcome

Timeframe: Within 180 days after administration of IdeS.

Population: The per protocol (PP) set comprises all patients in the SAS with \>1 post dose result. Data excluded for patients with \>1 protocol deviation. 1 patient lost the graft D77. Before analysis it was specified that the PP set should include all patients combined who had received the planned dose defined as 1 admin. initially which could be repeated if needed. The single as well as the repeated admin. are defined as the only planned dose. Hence, the results are presented for all patients together.

Donor specific antibodies (DSA) level at different time points within 180 days after administration of IdeS.

DSA levels were measured using the single antigen beads (SAB) anti-HLA assay. The levels were determined as mean fluorescence intensity (MFI).

Positive DSA (i.e. HLA antibodies) were defined as having a MFI value >3000.

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=18 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 Pre-dose	17 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 2 h	7 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 6 h	3 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 24 h	3 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 48 h	3 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 96 h	6 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 Day 7	9 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 Day 14	13 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 Day 28	10 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 Day 90	8 Patients with DSA (MFI>3000)	—	—
Number of Patients With Donor Specific Antibodies With an MFI Value >3000 Day 180	7 Patients with DSA (MFI>3000)	—	—

SECONDARY outcome

Timeframe: 2h, 6h, 24h after administration of IdeS.

Population: The full analysis set (FAS) comprises data from all patients in the safety analysis set (SAS) with available post-dose efficacy data. Before analysis it was specified that the analysis set should include all patients combined who had received the planned dose which was defined as 1 administration initially which could be repeated if needed. The single as well as the repeated administration are defined as the only planned dose. Consequently, the results are presented for all patients together.

Time to create a negative CDC crossmatch (XM) was defined as the first timepoint all CDC XM results were negative.

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=9 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Time to Create a Negative CDC Crossmatch Test All CDC XM tests negative at 2h	6 Participants	—	—
Time to Create a Negative CDC Crossmatch Test All CDC XM tests negative already pre-dose	3 Participants	—	—

SECONDARY outcome

Timeframe: 2h, 6h, and 24h after administration of IdeS

Population: The full analysis set (FAS) comprises data from all patients in the safety analysis set (SAS) with available post-dose efficacy data. Before analysis it was specified that the analysis set should include all patients combined who had received the planned dose which was defined as 1 administration initially which could be repeated if needed. The single as well as the repeated administration are defined as the only planned dose. Consequently, the results are presented for all patients together.

Time to create a negative FACS crossmatch (XM) was defined as the first timepoint all FACS XM results were negative.

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=19 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Time to Create a Negative FACS Crossmatch Test All FACS XM tests negative at 2h	8 Participants	—	—
Time to Create a Negative FACS Crossmatch Test All FACS XM tests negative at 6h	2 Participants	—	—
Time to Create a Negative FACS Crossmatch Test All FACS XM tests negative at 24h	7 Participants	—	—
Time to Create a Negative FACS Crossmatch Test Remained positive	2 Participants	—	—

SECONDARY outcome

Timeframe: Within 180 days after administration of IdeS

Population: The per protocol (PP) set comprises all patients in the SAS with \>1 post dose result. Data excluded for patients with \>1 protocol deviation. 1 patient lost the graft D77. Before analysis it was specified that the PP set should include all patients combined who had received the planned dose defined as 1 admin. initially which could be repeated if needed. The single as well as the repeated admin. are defined as the only planned dose. Hence, the results are presented for all patients together.

Estimated glomerular filtration rate (eGFR) was calculated as described by the MDRD equation. eGFR is a measure of kidney function.

eGFR for a kidney with normal function is 90 mL/min/1.72m2. Kidney disease is characterised by a decreased eGFR value.

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=18 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Kidney Function After IdeS Treatment Assessed by eGFR Day 28 · eGFR: <30 ml/min/1.72m2	5 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 28 · eGFR: 30-59 ml/min/1.72m2	9 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 28 · eGFR: >60 ml/min/1.72m2	4 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 90 · eGFR: <30 ml/min/1.72m2	4 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 90 · eGFR: 30-59 ml/min/1.72m2	7 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 90 · eGFR: >60 ml/min/1.72m2	6 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 180 · eGFR: <30 ml/min/1.72m2	2 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 180 · eGFR: 30-59 ml/min/1.72m2	11 Participants	—	—
Kidney Function After IdeS Treatment Assessed by eGFR Day 180 · eGFR: >60 ml/min/1.72m2	4 Participants	—	—

SECONDARY outcome

Timeframe: Within 180 days after administration of IdeS.

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. At Day 180 data was available for 7 patients receiving one dose and 1 patient receiving two doses.

The patient's immunoglobulin G (IgG) is cleaved by IdeS in two steps. The first cut separates one of the heavy chains from the Fc part, generating so called single-cleaved IgG (scIgG), and the second cut separates the other heavy chain from the Fc part, thus generating one F(ab')2 fragment and one Fc fragment. The IgG concentration measured for this outcome is the sum of intact and scIgG because the assay used cannot discriminate between the two. A decrease in IgG concentration therefore represents complete cleavage of the IgG molecules to Fc and F(ab')2 fragments.

Please note that intravenous IgG (IVIg) was administered Day 7.

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=15 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS n=3 Participants Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS n=18 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Serum IgG Concentration After Administration of IdeS IgG concentration (pre-dose)	10.11 mg/mL Geometric Coefficient of Variation 85.92	8.35 mg/mL Geometric Coefficient of Variation 55.37	9.79 mg/mL Geometric Coefficient of Variation 79.73
Serum IgG Concentration After Administration of IdeS IgG concentration (2 h)	1.19 mg/mL Geometric Coefficient of Variation 91.05	0.68 mg/mL Geometric Coefficient of Variation 165.87	1.08 mg/mL Geometric Coefficient of Variation 100.51
Serum IgG Concentration After Administration of IdeS IgG concentration (6 h)	0.55 mg/mL Geometric Coefficient of Variation 83.44	0.38 mg/mL Geometric Coefficient of Variation 109.18	0.52 mg/mL Geometric Coefficient of Variation 85.49
Serum IgG Concentration After Administration of IdeS IgG concentration (24 h)	0.37 mg/mL Geometric Coefficient of Variation 79.14	0.15 mg/mL Geometric Coefficient of Variation 42.46	0.32 mg/mL Geometric Coefficient of Variation 83.92
Serum IgG Concentration After Administration of IdeS IgG concentration (48 h)	0.51 mg/mL Geometric Coefficient of Variation 129.17	0.17 mg/mL Geometric Coefficient of Variation 45.57	0.43 mg/mL Geometric Coefficient of Variation 132.55
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 7 before IVIg)	0.64 mg/mL Geometric Coefficient of Variation 107.44	0.2 mg/mL Geometric Coefficient of Variation 96.88	0.53 mg/mL Geometric Coefficient of Variation 122.3
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 7 after IVIg)	16.52 mg/mL Geometric Coefficient of Variation 49.9	18.47 mg/mL Geometric Coefficient of Variation 23.91	16.89 mg/mL Geometric Coefficient of Variation 45.05
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 9)	15.34 mg/mL Geometric Coefficient of Variation 85.32	26.94 mg/mL Geometric Coefficient of Variation 50.82	16.85 mg/mL Geometric Coefficient of Variation 83
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 14)	13.48 mg/mL Geometric Coefficient of Variation 55.67	10.85 mg/mL Geometric Coefficient of Variation 53.42	13 mg/mL Geometric Coefficient of Variation 54.34
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 21)	10.57 mg/mL Geometric Coefficient of Variation 58.67	5.88 mg/mL Geometric Coefficient of Variation 88.3	9.58 mg/mL Geometric Coefficient of Variation 66.04
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 28)	10.25 mg/mL Geometric Coefficient of Variation 69.85	11.53 mg/mL Geometric Coefficient of Variation 66.45	10.45 mg/mL Geometric Coefficient of Variation 67.16
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 64)	11.91 mg/mL Geometric Coefficient of Variation 71.52	7.77 mg/mL Geometric Coefficient of Variation 45.82	11.09 mg/mL Geometric Coefficient of Variation 69.02
Serum IgG Concentration After Administration of IdeS IgG concentration (Day 180)	9.33 mg/mL Geometric Coefficient of Variation 42.58	8.99 mg/mL Geometric Coefficient of Variation 0	9.28 mg/mL Geometric Coefficient of Variation 39.21

SECONDARY outcome

Timeframe: Pre-dose to Day 14 after administration of IdeS.

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. The concentration vs time profiles for all 18 patients, including the 3 patients who received a second dose, were used to calculate Cmax after first dose. Cmax after the first dose occurred before the second dose was administered.

Cmax = Maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis)

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=18 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - Cmax (First Dose)	3.95 microgram/mL Geometric Coefficient of Variation 25.2	—	—

SECONDARY outcome

Timeframe: Pre-dose until Day 14 after administration of IdeS

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. The 3 patients received their second dose 11-13 hours after the first dose.

Cmax = Maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis)

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=3 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - Cmax (Second Dose)	4.13 micrograms/mL Geometric Coefficient of Variation 29.4	—	—

SECONDARY outcome

Timeframe: Pre-dose to Day 14 after administration of IdeS

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. (The mean result presented refers to the arithmetic mean) The concentration vs time profiles for all 18 patients, including the 3 patients who received a second dose, were used to calculate Tmax for the first dose. Cmax/Tmax for the first dose occurred before the second dose was administered.

Tmax = Time point for maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis)

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=18 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - Tmax (First Dose)	2.21 hours Standard Deviation 0.31	—	—

SECONDARY outcome

Timeframe: Pre-dose to Day 14 after administration of IdeS

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. The 3 subjects received their second dose 11-13 hours after the first dose. Tmax for the second dose was calculated from the start of the first dose. (The mean result presented refers to the arithmetic mean.)

Tmax = Time point for maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis)

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=3 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - Tmax (Second Dose)	15.98 hours Standard Deviation 5.50	—	—

SECONDARY outcome

Timeframe: Pre-dose to Day 14 after administration of IdeS.

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS.

AUC = Area under the plasma concentration versus time curve (Non-compartmental PK analysis)

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=9 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - AUC	156.09 hour*microgram/mL Geometric Coefficient of Variation 45.4	—	—

SECONDARY outcome

Timeframe: Pre-dose to Day 14 after administration of IdeS.

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS. (The mean result refers to the harmonic mean.)

Alpha-t1/2 = Half-life during distribution phase Beta-t1/2 = Half-life during elimination phase Non-compartmental PK analysis

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=9 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - t1/2 t1/2 (alpha)	4.58 hours Standard Deviation 3.85	—	—
Pharmacokinetics - t1/2 t1/2 (beta)	76.30 hours Standard Deviation 42.76	—	—

SECONDARY outcome

Timeframe: Pre-dose to Day 14

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS.

CL = Clearance Non compartmental PK analysis

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=9 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - CL	1.60 mL/h/kg Geometric Coefficient of Variation 45.4	—	—

SECONDARY outcome

Timeframe: Pre-dose to Day 14 after administration of IdeS

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS.

Vss = Volume of distribution at steady state Non compartmental PK analysis

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=9 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - Vss	0.14 L/kg Geometric Coefficient of Variation 26.9	—	—

SECONDARY outcome

Timeframe: Pre-dose to Day 14 after administration of IdeS.

Population: The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS

Vz = Volume of distribution during the elimination phase Non compartmental PK analysis

Outcome measures

Measure	FAS - One or Two Doses of 0.25 mg/kg BW IdeS n=9 Participants IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment Full analysis set (FAS) comprises all patients in the safety analysis set (SAS) with available post-dose efficacy data.	PP - Two Doses of 0.25 mg/kg BW IdeS Two (2) IdeS intravenous infusion IdeS: Two doses of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment Per Protocol (PP) analysis set consists of all patients who had at lease one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.	PP - One or Two Doses of 0.25 mg/kg BW IdeS IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment The Per Protocol (PP) set consists of all patients who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded.
Pharmacokinetics - Vz	0.19 L/kg Geometric Coefficient of Variation 27.0	—	—

Adverse Events

SAS - One Dose of IdeS (0.25 mg/kg BW)

Serious events: 12 serious events

Other events: 15 other events

Deaths: 0 deaths

SAS - Two Doses of IdeS (2 x 0.25 mg/kg BW)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

SAS - All Patients (One or Two Doses of IdeS (0.25 mg/kg BW))

Serious events: 15 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	SAS - One Dose of IdeS (0.25 mg/kg BW) n=16 participants at risk One (1) IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment The SAS consists of all patients dosed with any amount of IdeS.	SAS - Two Doses of IdeS (2 x 0.25 mg/kg BW) n=3 participants at risk Two (2) IdeS intravenous infusions IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment. The SAS consists of all patients dosed with any amount of IdeS.	SAS - All Patients (One or Two Doses of IdeS (0.25 mg/kg BW)) n=19 participants at risk One (1) or two (2) IdeS intravenous infusions. IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment. The SAS consists of all patients dosed with any amount of IdeS.
Vascular disorders Axillary vein thrombosis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Vascular disorders Superior vena cava syndrome	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Infusion related reaction	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Transplant failure	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Weaning failure	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Blood creatine increased	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Donor specific antibody present	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Immune system disorders Transplant rejection	43.8% 7/16 • Number of events 8 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	47.4% 9/19 • Number of events 10 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Thrombosis in device	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Abdominal pain lower	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Constipation	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Duodenal ulcer	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Dysphagia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Glomerulonephritis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Nephropathy toxic	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Device related infection	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Enterococcal bacteraemia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Influenza	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Osteomyelitis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Perinephric abscess	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Pyelonephritis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Urinary tract infection	12.5% 2/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Wound infection	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).

Other adverse events

Measure	SAS - One Dose of IdeS (0.25 mg/kg BW) n=16 participants at risk One (1) IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment The SAS consists of all patients dosed with any amount of IdeS.	SAS - Two Doses of IdeS (2 x 0.25 mg/kg BW) n=3 participants at risk Two (2) IdeS intravenous infusions IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment. The SAS consists of all patients dosed with any amount of IdeS.	SAS - All Patients (One or Two Doses of IdeS (0.25 mg/kg BW)) n=19 participants at risk One (1) or two (2) IdeS intravenous infusions. IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment. The SAS consists of all patients dosed with any amount of IdeS.
Vascular disorders Deep vein thrombosis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Vascular disorders Flushing	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Vascular disorders Haematoma	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Vascular disorders Hypertension	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Vascular disorders Hypotension	25.0% 4/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Vascular disorders Jugular vein thrombosis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Immune system disorders Drug hypersensitivity	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Immune system disorders Hypogammaglobulinaemia	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Immune system disorders Transplant rejection	6.2% 1/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Administration site pain	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Application site pain	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Application site pruritus	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Breakthrough pain	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Catheter site haemorrhage	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Catheter site pain	6.2% 1/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Chest discomfort	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Chest pain	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Generalised oedema	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Haemorrhagic cyst	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Oedema	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Oedema peripheral	12.5% 2/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 7 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Pain	12.5% 2/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Peripheral swelling	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
General disorders Pyrexia	25.0% 4/16 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Psychiatric disorders Affective disorder	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Psychiatric disorders Agitation	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Psychiatric disorders Anxiety	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Psychiatric disorders Depression	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Psychiatric disorders Hallucination	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Psychiatric disorders Insomnia	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Allergic transfusion reaction	6.2% 1/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Complications of transplant surgery	25.0% 4/16 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Delayed graft function	43.8% 7/16 • Number of events 7 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	42.1% 8/19 • Number of events 8 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Incision site pain	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Infusion related reaction	12.5% 2/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Procedural pain	18.8% 3/16 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Renal lymphocele	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Injury, poisoning and procedural complications Seroma	6.2% 1/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Alanine aminotransferase increased	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Aspartate aminotransferase increased	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Blood alkaline phosphatase increased	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Blood creatinine increased	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Blood potassium decreased	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Clostridium test positive	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Donor specific antibody present	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Hepatitis B core antibody positive	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Respiratory rate decreased	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Sapovirus test positive	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Transaminases increased	18.8% 3/16 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Investigations Urine output decreased	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Cardiac disorders Bradycardia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Cardiac disorders Pericardial effusion	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Cardiac disorders Tachycardia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Cough	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 2/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Hiccups	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Lung disorder	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Throat irritation	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Respiratory, thoracic and mediastinal disorders Throat lesion	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Blood and lymphatic system disorders Anaemia	56.2% 9/16 • Number of events 11 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	66.7% 2/3 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	57.9% 11/19 • Number of events 15 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Blood and lymphatic system disorders Anaemia of chronic disease	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Blood and lymphatic system disorders Leukopenia	25.0% 4/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Blood and lymphatic system disorders Neutropenia	25.0% 4/16 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	66.7% 2/3 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	31.6% 6/19 • Number of events 7 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Blood and lymphatic system disorders Thrombocytopenia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Nervous system disorders Headache	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Nervous system disorders Hypoaesthesia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Nervous system disorders Presyncope	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Nervous system disorders Tongue paralysis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Nervous system disorders Tremor	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Eye disorders Diplopia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Eye disorders Vision blurred	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Abdominal distension	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Abdominal pain lower	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Abdominal pain upper	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Constipation	43.8% 7/16 • Number of events 12 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	66.7% 2/3 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	47.4% 9/19 • Number of events 15 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Diarrhoea	43.8% 7/16 • Number of events 9 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	36.8% 7/19 • Number of events 9 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Dyspepsia	31.2% 5/16 • Number of events 7 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	26.3% 5/19 • Number of events 7 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Flatulence	12.5% 2/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Gastritis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Gastrooesophageal reflux disease	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Impaired gastric emptying	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Nausea	43.8% 7/16 • Number of events 7 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	42.1% 8/19 • Number of events 8 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Paraesthesia oral	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Perianal erythema	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Gastrointestinal disorders Vomiting	43.8% 7/16 • Number of events 9 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	36.8% 7/19 • Number of events 9 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Acute kidney injury	25.0% 4/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Bladder spasm	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Hypertonic bladder	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Micturition urgency	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Polyuria	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Proteinuria	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Renal and urinary disorders Renal cyst haemorrhage	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Hepatobiliary disorders Hepatocellular injury	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Skin and subcutaneous tissue disorders Angioedema	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Skin and subcutaneous tissue disorders Pruritus	37.5% 6/16 • Number of events 8 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	31.6% 6/19 • Number of events 8 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Skin and subcutaneous tissue disorders Swelling face	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Musculoskeletal and connective tissue disorders Back pain	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Musculoskeletal and connective tissue disorders Flank pain	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Musculoskeletal and connective tissue disorders Muscle spasms	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Endocrine disorders Hyperparathyroidism secondary	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Acidosis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Diabetes mellitus	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Fluid overload	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Fluid retention	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Gout	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hyperglycaemia	25.0% 4/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hyperkalaemia	31.2% 5/16 • Number of events 6 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	66.7% 2/3 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	36.8% 7/19 • Number of events 10 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hyperphosphataemia	12.5% 2/16 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hypertriglyceridaemia	25.0% 4/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	100.0% 3/3 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	36.8% 7/19 • Number of events 8 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hypoalbuminaemia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hypocalcaemia	25.0% 4/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hypoglycaemia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hypokalaemia	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	15.8% 3/19 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hypomagnesaemia	37.5% 6/16 • Number of events 8 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	100.0% 3/3 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	47.4% 9/19 • Number of events 13 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hyponatraemia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Hypophosphataemia	18.8% 3/16 • Number of events 3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	21.1% 4/19 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Iron deficiency	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Magnesium deficiency	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Metabolic acidosis	31.2% 5/16 • Number of events 5 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	66.7% 2/3 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	36.8% 7/19 • Number of events 7 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Type 2 diabetes mellitus	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Metabolism and nutrition disorders Vitamin D deficiency	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Bronchitis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Bronchitis viral	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Conjunctivitis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Cytomegalovirus viraemia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Ear infection	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Escherichia urinary tract infection	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Gastroenteritis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Nasopharyngitis	0.00% 0/16 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Perinephric abscess	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Pneumonia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Pseudomonas infection	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Pyuria	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Rhinitis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Upper respiratory tract infection	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	33.3% 1/3 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 2 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Urinary tract infection	12.5% 2/16 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	10.5% 2/19 • Number of events 4 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
Infections and infestations Viraemia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	0.00% 0/3 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).	5.3% 1/19 • Number of events 1 • Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study, including the follow-up period). Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation. A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).

Additional Information

Elisabeth Sonesson, Director Clinical Operations

Hansa Biopharma AB

Phone: +46 (0)708 54 86 46

Email: elisabeth.sonesson@hansabiopharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the study, one or more manuscripts for joint publication may be prepared in collaboration between the investigator(s) offered authorship and Hansa Medical AB. Any confidential information relating to the IMP or the study, including any data and results from the study will be the exclusive property of Hansa Medical AB. The investigator and any other persons involved in the trial will protect the confidentiality of the proprietary information belonging to Hansa Medical AB.
• Publication restrictions are in place

Restriction type: OTHER