Trial Outcomes & Findings for Open-Label Extension Study of Recombinant Human Arylsulfatase A (HGT-1111) in Late Infantile MLD (NCT NCT00681811)
NCT ID: NCT00681811
Last Updated: 2021-06-08
Results Overview
End of study was defined as until HGT-1111 was commercially available, the participant's participation was discontinued, or the study was terminated by the Sponsor.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline until end of study (Week 139)
Results posted on
2021-06-08
Participant Flow
Children with an established diagnosis of late metachromatic leukodystrophy (MLD) due to arylsulfatase A (ASA) deficiency were recruited.
All participants who completed Study HGT-MLD-048 (NCT00633139) participated in this study.
Participant milestones
| Measure |
100 U/kg HGT-1111
Participants received 100 units per kilogram (U/kg) of HGT1111 intravenous (IV) infusion every other week.
|
200 U/kg HGT-1111
Participants received 200 U/kg of HGT1111 IV infusion every other week.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
100 U/kg HGT-1111
Participants received 100 units per kilogram (U/kg) of HGT1111 intravenous (IV) infusion every other week.
|
200 U/kg HGT-1111
Participants received 200 U/kg of HGT1111 IV infusion every other week.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Non-compliance
|
0
|
1
|
Baseline Characteristics
Open-Label Extension Study of Recombinant Human Arylsulfatase A (HGT-1111) in Late Infantile MLD
Baseline characteristics by cohort
| Measure |
100 U/kg HGT1111
n=6 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week.
|
200 U/kg
n=5 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.14 months
STANDARD_DEVIATION 10.526 • n=5 Participants
|
49.99 months
STANDARD_DEVIATION 8.752 • n=7 Participants
|
51.71 months
STANDARD_DEVIATION 9.420 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until end of study (Week 139)Population: Safety population was defined as all enrolled participants who received at least one study infusion (or any portion of a dose) of HGT-1111.
End of study was defined as until HGT-1111 was commercially available, the participant's participation was discontinued, or the study was terminated by the Sponsor.
Outcome measures
| Measure |
100 U/kg HGT-1111 (Month 6)
n=6 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
200 U/kg HGT-1111 (Month 6)
n=5 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
100 U/kg HGT-1111 (Month 12)
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
200 U/kg HGT-1111 (Month 12)
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
100 U/kg HGT-1111 (Month 18)
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
200 U/kg HGT-1111 (Month 18)
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
100 U/kg HGT-1111 (Month 24)
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
200 U/kg HGT-1111 (Month 24)
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
|---|---|---|---|---|---|---|---|---|
|
Days of Exposure to HGT-1111
|
644.7 Days
Standard Deviation 276.11
|
544.8 Days
Standard Deviation 397.27
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until end of study (Week 139)Population: Safety population. "Number of participants analysed" signifies participants who were evaluable for the respective arms under this outcome measure.
Level of CSF sulfatide measured at 6-month intervals in HGT-MLD-049 (NCT00681811).
Outcome measures
| Measure |
100 U/kg HGT-1111 (Month 6)
n=5 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
200 U/kg HGT-1111 (Month 6)
n=4 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
100 U/kg HGT-1111 (Month 12)
n=5 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
200 U/kg HGT-1111 (Month 12)
n=3 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
100 U/kg HGT-1111 (Month 18)
n=3 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
200 U/kg HGT-1111 (Month 18)
n=3 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
100 U/kg HGT-1111 (Month 24)
n=1 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
200 U/kg HGT-1111 (Month 24)
n=2 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
|---|---|---|---|---|---|---|---|---|
|
Level of Cerebrospinal Fluid (CSF) Sulfatide
|
685.0 nanomole per liter (nmol/L)
Standard Deviation 522.79
|
732.5 nanomole per liter (nmol/L)
Standard Deviation 545.06
|
745.0 nanomole per liter (nmol/L)
Standard Deviation 525.12
|
1150.0 nanomole per liter (nmol/L)
Standard Deviation 676.39
|
700.0 nanomole per liter (nmol/L)
Standard Deviation 526.78
|
850.0 nanomole per liter (nmol/L)
Standard Deviation 491.81
|
900.0 nanomole per liter (nmol/L)
Standard Deviation NA
Standard deviation could not be reported as there was only 1 evaluable participant.
|
837.5 nanomole per liter (nmol/L)
Standard Deviation 441.94
|
SECONDARY outcome
Timeframe: Baseline until end of study (Week 139)Population: Safety population. "Number of participants analysed" signifies participants who were evaluable for the respective arms under this outcome measure. No participants were analysed after Month 18, hence, data were not available after Month 18.
Level of white matter metabolites \[N-acetyl Aspartate (NAA)\] measured at 6-month intervals in HGT-MLD-049 (NCT00681811).
Outcome measures
| Measure |
100 U/kg HGT-1111 (Month 6)
n=4 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
200 U/kg HGT-1111 (Month 6)
n=4 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
100 U/kg HGT-1111 (Month 12)
n=5 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
200 U/kg HGT-1111 (Month 12)
n=2 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
100 U/kg HGT-1111 (Month 18)
n=2 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
200 U/kg HGT-1111 (Month 18)
n=2 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
100 U/kg HGT-1111 (Month 24)
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
200 U/kg HGT-1111 (Month 24)
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
|---|---|---|---|---|---|---|---|---|
|
Level of White Matter Metabolites
|
0.528 nmol/L
Standard Deviation 0.176
|
0.385 nmol/L
Standard Deviation 0.237
|
0.598 nmol/L
Standard Deviation 0.208
|
0.470 nmol/L
Standard Deviation 0.198
|
0.510 nmol/L
Standard Deviation 0.141
|
0.805 nmol/L
Standard Deviation 0.445
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until end of study (Week 139)Population: Safety population. "Number of participants analysed" signifies participants who were evaluable for the respective arms under this outcome measure.
Gross motor function was measured using GMFM-88 at 6-month intervals. The GMFM-88 item scores were summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) to 264 (maximum). Decrease in GMFM score indicates disease progression.
Outcome measures
| Measure |
100 U/kg HGT-1111 (Month 6)
n=5 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
200 U/kg HGT-1111 (Month 6)
n=5 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
|
100 U/kg HGT-1111 (Month 12)
n=5 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
200 U/kg HGT-1111 (Month 12)
n=3 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
|
100 U/kg HGT-1111 (Month 18)
n=4 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
200 U/kg HGT-1111 (Month 18)
n=2 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
|
100 U/kg HGT-1111 (Month 24)
n=2 Participants
Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
200 U/kg HGT-1111 (Month 24)
n=2 Participants
Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
|
|---|---|---|---|---|---|---|---|---|
|
Score of Gross Motor Function Measurement (GMFM)
|
16.8 scores on a scale
Standard Deviation 11.30
|
9.2 scores on a scale
Standard Deviation 11.71
|
15.6 scores on a scale
Standard Deviation 15.84
|
8.7 scores on a scale
Standard Deviation 9.29
|
16.8 scores on a scale
Standard Deviation 13.60
|
9.0 scores on a scale
Standard Deviation 5.66
|
14.5 scores on a scale
Standard Deviation 10.61
|
13.0 scores on a scale
Standard Deviation 11.31
|
Adverse Events
100 U/kg HGT1111
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
200 U/kg HGT1111
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 U/kg HGT1111
n=6 participants at risk
Participants received 100 U/kg of HGT1111 IV infusion every other week.
|
200 U/kg HGT1111
n=5 participants at risk
Participants received 200 U/kg of HGT1111 IV infusion every other week.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Lower respiratory track infection
|
16.7%
1/6 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Catheter bacteraemia
|
16.7%
1/6 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Pseudomonas infection
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
Other adverse events
| Measure |
100 U/kg HGT1111
n=6 participants at risk
Participants received 100 U/kg of HGT1111 IV infusion every other week.
|
200 U/kg HGT1111
n=5 participants at risk
Participants received 200 U/kg of HGT1111 IV infusion every other week.
|
|---|---|---|
|
Vascular disorders
Pallor
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
60.0%
3/5 • Number of events 8 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
General disorders
Generalised oedema
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
General disorders
Pyrexia
|
66.7%
4/6 • Number of events 16 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
80.0%
4/5 • Number of events 4 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Psychiatric disorders
Mental status changes
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Reproductive system and breast disorders
Phimosis
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Investigations
Blood iron increased
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Investigations
Heart rate increased
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Investigations
Platelet count increased
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Dystonia
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Depressed level of consciousness
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Epilepsy
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Febrile convulsion
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Hypotonia
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Muscle spasticity
|
33.3%
2/6 • Number of events 5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Eye disorders
Conjunctival oedema
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Eye disorders
Visual acuity reduced
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Eye disorders
Eyelid oedema
|
33.3%
2/6 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
2/6 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 15 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
60.0%
3/5 • Number of events 10 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Reflux gastritis
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 9 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
60.0%
3/5 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Gastrointestinal disorders
Regurgitation of food
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Skin and subcutaneous tissue disorders
Urticaria generalised
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 4 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
16.7%
1/6 • Number of events 4 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Number of events 9 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
60.0%
3/5 • Number of events 6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 13 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 11 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Gastroenteritis
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Ear infection
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Bronchitis acute
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Bronchitis
|
50.0%
3/6 • Number of events 4 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
60.0%
3/5 • Number of events 4 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Eye infection
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 3 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Nasopharyngitis
|
66.7%
4/6 • Number of events 12 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 2 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Pharyngitis
|
33.3%
2/6 • Number of events 5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
40.0%
2/5 • Number of events 4 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Viral pharyngitis
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Varicella
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
20.0%
1/5 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
|
Infections and infestations
Tooth infection
|
16.7%
1/6 • Number of events 1 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
0.00%
0/5 • Up to end of study (Week 139) which was defined as until HGT-1111 was commercially available, the patient's participation was discontinued, or the study was terminated by the Sponsor.
All other adverse events (\>5% reporting frequency) reported here are related to drug administration, all were infusion-related reactions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60