Trial Outcomes & Findings for Open-Label Extension Study Evaluating Long Term Safety in Patients With Type 1 Gaucher Disease Receiving DRX008A (ERT) (NCT NCT00391625)
NCT ID: NCT00391625
Last Updated: 2021-06-22
Results Overview
Overall Summary of Treatment-emergent Adverse Events-Safety Population
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 84 months
Results posted on
2021-06-22
Participant Flow
The first patient was enrolled on 3 February 2005.
Recruitment of patients was limited to those patient who completed first in man, Phase I/II study TKT025, elected to continue to receive treatment with velaglucerase alfa and met the study inclusion criteria.
Participant milestones
| Measure |
GA-GCB
15-60 U/kg every other week via intravenous infusion
|
|---|---|
|
Baseline
STARTED
|
10
|
|
Baseline
COMPLETED
|
10
|
|
Baseline
NOT COMPLETED
|
0
|
|
Month 14
STARTED
|
10
|
|
Month 14
COMPLETED
|
9
|
|
Month 14
NOT COMPLETED
|
1
|
|
Month 50
STARTED
|
9
|
|
Month 50
COMPLETED
|
8
|
|
Month 50
NOT COMPLETED
|
1
|
|
Month 84
STARTED
|
8
|
|
Month 84
COMPLETED
|
8
|
|
Month 84
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
GA-GCB
15-60 U/kg every other week via intravenous infusion
|
|---|---|
|
Month 14
Withdrawal by Subject
|
1
|
|
Month 50
Physician Decision
|
1
|
Baseline Characteristics
Open-Label Extension Study Evaluating Long Term Safety in Patients With Type 1 Gaucher Disease Receiving DRX008A (ERT)
Baseline characteristics by cohort
| Measure |
GA-GCB
n=10 Participants
15-60 U/kg every other week via intravenous infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 16.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 84 monthsPopulation: ITT patient population
Overall Summary of Treatment-emergent Adverse Events-Safety Population
Outcome measures
| Measure |
Number (#) Experienced no Adverse Event (AE)
n=10 Participants
15-60 U/kg every other week via intravenous infusion
|
# Experienced at Least 1 AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Infusion-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Life-threatening AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Serious AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Serious AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Discontinued Due to an AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Deaths
n=10 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Evaluation of Long Term Safety
|
0 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, then every 12 monthsPopulation: Intent to treat (ITT) patient population
Outcome measures
| Measure |
Number (#) Experienced no Adverse Event (AE)
n=10 Participants
15-60 U/kg every other week via intravenous infusion
|
# Experienced at Least 1 AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Infusion-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Life-threatening AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Serious AE
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Serious AE
15-60 U/kg, every other week Intravenously
|
# Discontinued Due to an AE
15-60 U/kg, every other week Intravenously
|
# Deaths
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Hemoglobin Concentration
|
20.91 Percent Change from Baseline
Standard Error 1.962
|
20.74 Percent Change from Baseline
Standard Error 2.251
|
19.17 Percent Change from Baseline
Standard Error 2.365
|
20.96 Percent Change from Baseline
Standard Error 3.248
|
16.58 Percent Change from Baseline
Standard Error 2.437
|
17.48 Percent Change from Baseline
Standard Error 2.317
|
17.97 Percent Change from Baseline
Standard Error 2.460
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, then every 12 monthsPopulation: ITT patient population
Outcome measures
| Measure |
Number (#) Experienced no Adverse Event (AE)
n=10 Participants
15-60 U/kg every other week via intravenous infusion
|
# Experienced at Least 1 AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Infusion-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Life-threatening AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Serious AE
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Serious AE
15-60 U/kg, every other week Intravenously
|
# Discontinued Due to an AE
15-60 U/kg, every other week Intravenously
|
# Deaths
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Platelet Counts
|
78.21 Percent Change from Baseline
Standard Error 15.127
|
99.60 Percent Change from Baseline
Standard Error 15.324
|
111.57 Percent Change from Baseline
Standard Error 13.723
|
132.61 Percent Change from Baseline
Standard Error 18.461
|
139.73 Percent Change from Baseline
Standard Error 27.890
|
126.20 Percent Change from Baseline
Standard Error 20.445
|
114.93 Percent Change from Baseline
Standard Error 21.783
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 24, then every 9 or 12 monthsPopulation: ITT
Outcome measures
| Measure |
Number (#) Experienced no Adverse Event (AE)
n=10 Participants
15-60 U/kg every other week via intravenous infusion
|
# Experienced at Least 1 AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Infusion-related AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Severe AE
n=10 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Life-threatening AE
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Serious AE
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Serious AE
15-60 U/kg, every other week Intravenously
|
# Discontinued Due to an AE
15-60 U/kg, every other week Intravenously
|
# Deaths
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Liver Volume
|
-28.00 Percent Change from Baseline
Standard Error 4.835
|
-30.95 Percent Change from Baseline
Standard Error 3.627
|
-39.35 Percent Change from Baseline
Standard Error 4.739
|
-38.99 Percent Change from Baseline
Standard Error 4.567
|
-39.78 Percent Change from Baseline
Standard Error 4.821
|
-42.07 Percent Change from Baseline
Standard Error 4.705
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 24, then every 9 or 12 monthsPopulation: ITT (One patient was excluded due to an intravascular metallic device that prevented accurate spleen evaluation.)
Outcome measures
| Measure |
Number (#) Experienced no Adverse Event (AE)
n=9 Participants
15-60 U/kg every other week via intravenous infusion
|
# Experienced at Least 1 AE
n=9 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related AE
n=9 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Infusion-related AE
n=9 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Severe AE
n=9 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Severe AE
n=9 Participants
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Life-threatening AE
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Serious AE
15-60 U/kg, every other week Intravenously
|
# Experienced at Least 1 Drug-related Serious AE
15-60 U/kg, every other week Intravenously
|
# Discontinued Due to an AE
15-60 U/kg, every other week Intravenously
|
# Deaths
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Spleen Size
|
-66.86 Percent Change from Baseline
Standard Error 6.286
|
-68.09 Percent Change from Baseline
Standard Error 6.204
|
-73.56 Percent Change from Baseline
Standard Error 6.717
|
-73.97 Percent Change from Baseline
Standard Error 6.663
|
-75.96 Percent Change from Baseline
Standard Error 6.819
|
-77.82 Percent Change from Baseline
Standard Error 7.002
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
GA-GCB
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GA-GCB
n=10 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Scar
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
10.0%
1/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
Other adverse events
| Measure |
GA-GCB
n=10 participants at risk
|
|---|---|
|
Infections and infestations
Influenza
|
60.0%
6/10 • Number of events 11 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
5/10 • Number of events 5 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Urinary tract infection
|
40.0%
4/10 • Number of events 6 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Eye infection
|
30.0%
3/10 • Number of events 4 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Nail infection
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Rhinitis
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Acarodermatitis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Bronchitis viral
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Fungal rash
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Helicobacter infection
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Herpes simplex
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Localised infection
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Otitis media
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Periodontal infection
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Vaginal infection
|
10.0%
1/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Tinea versicolour
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Tooth infection
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
vaginal candidiasis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Immune system disorders
Drug hypersensitivity
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Viral infection
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Condyloma acuminatum
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Infections and infestations
Cystitis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Sinus headache
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Asthenopia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Blepharitis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Cataract
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Eye discharge
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Eye inflammation
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Eyelid oedema
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Ocular hyperaemia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Visual acuity reduced
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Eye disorders
Vitreous detachment
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Ear and labyrinth disorders
Hypoacusis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Cardiac disorders
Palpitations
|
20.0%
2/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Vascular disorders
Hot flush
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
50.0%
5/10 • Number of events 11 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
30.0%
3/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
2/10 • Number of events 6 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
70.0%
7/10 • Number of events 19 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
4/10 • Number of events 5 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Gingival bleeding
|
40.0%
4/10 • Number of events 6 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 11 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
30.0%
3/10 • Number of events 4 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
30.0%
3/10 • Number of events 6 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Number of events 4 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Enterocolitis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Gingivitis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
10.0%
1/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Gastrointestinal disorders
Inguinal hernia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
10.0%
1/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Scar
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
80.0%
8/10 • Number of events 21 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
60.0%
6/10 • Number of events 11 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
4/10 • Number of events 8 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
30.0%
3/10 • Number of events 6 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
30.0%
3/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
30.0%
3/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
20.0%
2/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spine flattening
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Inflammation
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Infusion site extravasation
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Sensation of pressure
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Investigations
Blood cholesterol increased
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Investigations
Blood triglycerides increased
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Investigations
Heart rate increased
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Investigations
Lipids increased
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Investigations
Liver function test abnormal
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Fall
|
30.0%
3/10 • Number of events 4 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
20.0%
2/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.0%
1/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Sunburn
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Surgical and medical procedures
Endodontic procedure
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
10.0%
1/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 10 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Number of events 12 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Hypoaesthesia
|
20.0%
2/10 • Number of events 4 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Paraesthesia
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Aphasia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Sciatica
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Hyperaesthesia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Migraine
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Muscle Spasticity
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Renal and urinary disorders
Micturition urgency
|
30.0%
3/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Reproductive system and breast disorders
Cervix disorder
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Reproductive system and breast disorders
Dyspareunia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Reproductive system and breast disorders
Menorrhagia
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Pyrexia
|
60.0%
6/10 • Number of events 7 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 5 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Asthenia
|
30.0%
3/10 • Number of events 3 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Malaise
|
20.0%
2/10 • Number of events 2 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • Number of events 4 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Adverse drug reaction
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
|
General disorders
Feeling hot
|
10.0%
1/10 • Number of events 1 • On or after the first infusion in study TK025EXT, up to 7 years.
|
Additional Information
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