Trial Outcomes & Findings for An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease (NCT NCT00635427)

Last Updated: 2021-06-10

Results Overview

Safety was evaluated by an analysis of adverse events (AEs), concomitant medication use, clinical laboratory tests, vital signs during the infusion of study drug, physical examination, and the development of anti-velaglucerase alfa. No formal comparisons or statistical tests were applied for the safety analyses, including for differences between the groups.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

95 participants

Primary outcome timeframe

Baseline to termination of study

Results posted on

2021-06-10

Participant Flow

The first participant was enrolled in the study on 13 March 2008 and the last participant completed study procedures on 28 December 2012.

2 participants who did not have type 1 Gaucher disease were withdrawn from the intent-to-treat (ITT) set as per the statistical analysis plan and removed from the long-term efficacy analyses in this study, needed to support the interpretation of the long-term efficacy results. Hence, 93 of 95 participants were included in the HGT-GCB-044 ITT set.

Participant milestones

Participant milestones
Measure	VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg) -TKT032) VPRIV 45 U/kg, IV, every other week (EOW) for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044	VPRIV 60 U/kg (Parent Study- VPRIV (60 U/kg)-TKT032) VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625)	VPRIV 60 U/kg (Parent Study- VPRIV (60U/kg) HGT-GCB-039) VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg)HGT-GCB-039) imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV(15-60 U/kg)TKT034) VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647) and continued in HGT-GCB-044 at the same dose as prescribed in TKT034
Overall Study STARTED	13	12	16	16	38
Overall Study COMPLETED	1	6	5	7	30
Overall Study NOT COMPLETED	12	6	11	9	8

Reasons for withdrawal

Reasons for withdrawal
Measure	VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg) -TKT032) VPRIV 45 U/kg, IV, every other week (EOW) for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044	VPRIV 60 U/kg (Parent Study- VPRIV (60 U/kg)-TKT032) VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625)	VPRIV 60 U/kg (Parent Study- VPRIV (60U/kg) HGT-GCB-039) VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg)HGT-GCB-039) imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV(15-60 U/kg)TKT034) VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647) and continued in HGT-GCB-044 at the same dose as prescribed in TKT034
Overall Study Refusal Of Required DiagnosticEvaluation	0	0	1	0	0
Overall Study Death	0	0	0	1	0
Overall Study Termination Of Study By Sponsor	12	6	10	6	6
Overall Study Withdrawal Of Consent	0	0	0	2	2

Baseline Characteristics

An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg)-TKT032) n=12 Participants VPRIV 45 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044.	VPRIV 60 U/kg (Parent Study VPRIV (60 U/kg)-TKT032) n=11 Participants VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625).	VPRIV 60 U/kg (Parent Study VPRIV (60U/kg) HGT-GCB-039) n=16 Participants VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631).	VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg) HGT-GCB-039 n=16 Participants Imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 Participants VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044	Total n=93 Participants Total of all reporting groups
Age, Continuous	32.5 Years STANDARD_DEVIATION 16.75 • n=5 Participants	22 Years STANDARD_DEVIATION 11.08 • n=7 Participants	32.9 Years STANDARD_DEVIATION 16.14 • n=5 Participants	25 Years STANDARD_DEVIATION 17.33 • n=4 Participants	34.3 Years STANDARD_DEVIATION 17.94 • n=21 Participants	31.4 Years STANDARD_DEVIATION 17.15 • n=8 Participants
Age, Customized At least 18 years	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants	22 Participants n=8 Participants
Age, Customized Between 18 and 65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	26 Participants n=21 Participants	68 Participants n=8 Participants
Age, Customized Greater than or equal to 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	18 Participants n=21 Participants	46 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	20 Participants n=21 Participants	47 Participants n=8 Participants
Splenectomy status Yes	0 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	3 Participants n=21 Participants	22 Participants n=8 Participants
Splenectomy status No	12 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	35 Participants n=21 Participants	71 Participants n=8 Participants
Baseline hemoglobin concentration per treatment group	10.68 gram per deciliter n=5 Participants	10.68 gram per deciliter n=7 Participants	11.56 gram per deciliter n=5 Participants	10.58 gram per deciliter n=4 Participants	13.82 gram per deciliter n=21 Participants	12.09 gram per deciliter n=8 Participants
Baseline platelet counts per treatment group	69.3 x10^9/L n=5 Participants	79.4 x10^9/L n=7 Participants	160.1 x10^9/L n=5 Participants	186.3 x10^9/L n=4 Participants	165.4 x10^9/L n=21 Participants	144.81 x10^9/L n=8 Participants
Baseline liver volume per treatment group	1.64 Percent (%) body weight n=5 Participants	1.63 Percent (%) body weight n=7 Participants	1.59 Percent (%) body weight n=5 Participants	1.68 Percent (%) body weight n=4 Participants	0.82 Percent (%) body weight n=21 Participants	1.302 Percent (%) body weight n=8 Participants
Baseline Spleen volume per treatment group	23.08 Multiple of Normal n=5 Participants	18.48 Multiple of Normal n=7 Participants	12.69 Multiple of Normal n=5 Participants	23.52 Multiple of Normal n=4 Participants	4.1 Multiple of Normal n=21 Participants	13.07 Multiple of Normal n=8 Participants

PRIMARY outcome

Timeframe: Baseline to termination of study

Population: All participants who received at least 1 infusion (full or partial) of study drug were evaluated for safety (ie, were included in the safety population). There were 95 participants in the safety population.

Outcome measures

Outcome measures
Measure	VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039) n=41 Participants This is the overall velaglucerase alfa group consisting of the following population: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039) n=16 Participants imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 Participants VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
Overall Summary of Treatment Emergent Adverse Events Experienced no AEs	3 Participants	1 Participants	3 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 AE	38 Participants	15 Participants	35 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 drug-related AE	9 Participants	7 Participants	8 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 infusion-related AE	5 Participants	1 Participants	5 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 severe AE	4 Participants	3 Participants	4 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 drug-related severe AE	0 Participants	0 Participants	0 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 Life-threatening AE	0 Participants	0 Participants	0 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 drug-related Life-threateni	0 Participants	0 Participants	0 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 serious AE	6 Participants	4 Participants	6 Participants
Overall Summary of Treatment Emergent Adverse Events Experienced at least 1 drug-related serious AE	0 Participants	0 Participants	0 Participants
Overall Summary of Treatment Emergent Adverse Events Discontinued due to an AE	0 Participants	0 Participants	0 Participants
Overall Summary of Treatment Emergent Adverse Events Deaths	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to 24 months

Outcome measures

Outcome measures
Measure	VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039) n=39 Participants This is the overall velaglucerase alfa group consisting of the following population: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039) n=16 Participants imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 Participants VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
Change From Baseline to 24 Months in Hemoglobin Concentration for Each Treatment Group	2.75 (g/dL) Interval 2.28 to 3.22	2.00 (g/dL) Interval 1.25 to 2.75	-0.05 (g/dL) Interval -0.34 to 0.25

SECONDARY outcome

Timeframe: Baseline to 24 months

Outcome measures

Outcome measures
Measure	VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039) n=39 Participants This is the overall velaglucerase alfa group consisting of the following population: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039) n=16 Participants imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 Participants VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
Change From Baseline to 24 Months in Platelet Counts for Each Treatment Group	87.85 (10^9/L) Interval 72.69 to 103.0	160.94 (10^9/L) Interval 117.22 to 204.66	9.03 (10^9/L) Interval -2.6 to 20.66

SECONDARY outcome

Timeframe: Baseline to 24 months

Outcome measures

Outcome measures
Measure	VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039) n=39 Participants This is the overall velaglucerase alfa group consisting of the following population: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039) n=16 Participants imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 Participants VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
Change From Baseline to 24 Months in Normalized Liver Volume for Each Treatment Group	-1.206 % Body weight Interval -1.501 to -0.912	-1.688 % Body weight Interval -2.164 to -1.211	-0.026 % Body weight Interval -0.1 to 0.047

SECONDARY outcome

Timeframe: Baseline to 24 months

Outcome measures

Outcome measures
Measure	VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039) n=39 Participants This is the overall velaglucerase alfa group consisting of the following population: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039) n=16 Participants imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 Participants VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
Percentage Change From Baseline to 24 Months in Normalized Spleen Volume for Each Treatment Group	-64.49 Precent (%) change Interval -69.26 to -59.73	-63.82 Precent (%) change Interval -89.65 to -37.98	-8.04 Precent (%) change Interval -14.0 to -2.08

Adverse Events

VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Shire's agreements with investigators vary. All agreements provide Shire the right to embargo communications regarding trial results prior to public release for a period ≤180 days from the time submitted to Shire for review. Shire does not prohibit publication, but can require the removal of confidential information(excluding trial results) and can request postponement of a single-center publication until after disclosure of the trial's multi-center publication
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 participants at risk VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044	VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039) n=41 participants at risk This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039) n=16 participants at risk imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
Blood and lymphatic system disorders Splenomegaly	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Abdominal hernia	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Umbilical hernia	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
General disorders Non-cardiac chest pain	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Bronchopneumonia	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Respiratory tract infection	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Urinary tract infection	2.6% 1/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Injury, poisoning and procedural complications Post procedural haematoma	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	4.9% 2/41 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.5% 2/16 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Nervous system disorders Convulsion	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Nervous system disorders Syncope	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Renal and urinary disorders Renal colic	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Vascular disorders Phlebitis	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.

Other adverse events
Measure	VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034) n=38 participants at risk VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044	VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039) n=41 participants at risk This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups: VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)	VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039) n=16 participants at risk imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
Gastrointestinal disorders Abdominal pain	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	7.3% 3/41 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Abdominal pain upper	7.9% 3/38 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	9.8% 4/41 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.5% 2/16 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Diarrhoea	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	4.9% 2/41 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Dyspepsia	5.3% 2/38 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	7.3% 3/41 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Toothache	5.3% 2/38 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	14.6% 6/41 • Number of events 7 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.5% 2/16 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
General disorders Fatigue	18.4% 7/38 • Number of events 8 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	7.3% 3/41 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
General disorders Pyrexia	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	14.6% 6/41 • Number of events 10 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Bronchitis	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.2% 5/41 • Number of events 13 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Bronchitis acute	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.2% 5/41 • Number of events 5 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Gastroenteritis	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	17.1% 7/41 • Number of events 10 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Influenza	10.5% 4/38 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	14.6% 6/41 • Number of events 10 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	25.0% 4/16 • Number of events 12 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Nasopharyngitis	42.1% 16/38 • Number of events 31 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	26.8% 11/41 • Number of events 20 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	18.8% 3/16 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Pharyngitis	13.2% 5/38 • Number of events 11 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	4.9% 2/41 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Tinea versicolour	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	9.8% 4/41 • Number of events 13 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Tonsillitis	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	9.8% 4/41 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Upper respiratory tract infection	23.7% 9/38 • Number of events 9 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	9.8% 4/41 • Number of events 7 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	37.5% 6/16 • Number of events 14 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Urinary tract infection	7.9% 3/38 • Number of events 5 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	7.3% 3/41 • Number of events 5 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Arthralgia	23.7% 9/38 • Number of events 13 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	34.1% 14/41 • Number of events 33 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.5% 2/16 • Number of events 34 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Back pain	10.5% 4/38 • Number of events 7 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.2% 5/41 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Bone pain	18.4% 7/38 • Number of events 12 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	17.1% 7/41 • Number of events 20 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.5% 2/16 • Number of events 7 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 2/38 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	7.3% 3/41 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	10.5% 4/38 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.2% 5/41 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Musculoskeletal and connective tissue disorders Shoulder pain	7.9% 3/38 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	4.9% 2/41 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Nervous system disorders Headache	15.8% 6/38 • Number of events 10 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	17.1% 7/41 • Number of events 16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	25.0% 4/16 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Nervous system disorders Paraesthesia	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	4.9% 2/41 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Respiratory, thoracic and mediastinal disorders Cough	13.2% 5/38 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	18.8% 3/16 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	13.2% 5/38 • Number of events 8 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	7.3% 3/41 • Number of events 4 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Vascular disorders Hypertension	10.5% 4/38 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	12.2% 5/41 • Number of events 6 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Rectal haemorrhage	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Gastrointestinal disorders Vomiting	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
General disorders Adverse drug reaction	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
General disorders Chest discomfort	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
General disorders Gait disturbance	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
General disorders Influenza like illness	5.3% 2/38 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Dental caries	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	2.4% 1/41 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Diarrhoea infectious	5.3% 2/38 • Number of events 2 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/16 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Hepatitis a	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Hordeolum	2.6% 1/38 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	4.9% 2/41 • Number of events 3 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/38 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	0.00% 0/41 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.	6.2% 1/16 • Number of events 1 • Treatment Emergent Adverse Events were defined as AEs which occurred on or after the time of the first infusion in HGT-GCB-044, until 30 days after the participant's last study infusion. AEs may have been discovered through observation or examination, and questioning of the participant, complaint by the participant, or by an abnormal clinical laboratory value. Severity of AEs was to be assessed by the investigator and recorded on the electronic case report form (eCRF)regardless of the severity or relationship to study drug.