Trial Outcomes & Findings for Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease (NCT NCT03539952)
NCT ID: NCT03539952
Last Updated: 2025-07-02
Results Overview
The primary outcome of efficacy was serum NCC by speciation assay (μg/L), with comparative analysis of mean difference between the two groups 24 weeks after randomization. The non-inferiority margin was set at -50 μg/L.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Week 36
Results posted on
2025-07-02
Participant Flow
The first patient was enrolled on 03 September 2018, the last patient completed the Week 36 visit (for primary analysis) on 19 August 2020, and the last patient visit in the study was on 18 January 2022.
After enrolment, patients entered a 12-week run-in period. This is referred to the Penicillamine Baseline Period. During this time, all patients received penicillamine, allowing dose adjustments to reach clinical and laboratory stability criteria. At the end of this 12-week period, patients were randomized 1:1 ratio to either continue penicillamine or receive TETA 4HCl if protocol definition of stability were met in addition to an independent assessment from a panel of WD specialists.
Participant milestones
| Measure |
Penicillamine
Male and female clinically stable Wilson Disease patients, aged ≥18 and ≤75, receiving penicillamine treatment for at least 1 year, stable dose for at least 4 months prior to enrolment. Patients continued on their current penicillamine therapy from week 1 till 12, the baseline period. When confirmed stable, patients were randomized to continue penicillamine (control) treatment for the 24 weeks post-randomization phase (week 12-36). Patients completing the 24-weeks post-randomization phase, were offered to enter a 24 week extension period on their allocated (control) Penicillamine. At the end of the extension period (study end), all patients were offered continuing involvement by switching to TETA 4HCl.
|
TETA 4HCl
Male and female clinically stable Wilson Disease patients, aged ≥18 and ≤75, receiving penicillamine treatment for at least 1 year, stable dose for at least 4 months prior to enrolment. Patients continued on their current penicillamine therapy from week 1 till 12, the baseline period. When confirmed stable, patients were randomized to open label TETA 4HCl (intervention) treatment for the 24 weeks post-randomization phase (week 12-36). Patients completing the 24-weeks post-randomization phase, were offered to enter a 24 week extension period on their allocated (intervention) TETA 4HCl. At the end of the extension period (study end), all patients were offered continuing involvement by switching to or continuing TETA 4HCl.
|
|---|---|---|
|
Penicillamine Baseline Period (Day1-W12)
STARTED
|
77
|
0
|
|
Penicillamine Baseline Period (Day1-W12)
COMPLETED
|
53
|
0
|
|
Penicillamine Baseline Period (Day1-W12)
NOT COMPLETED
|
24
|
0
|
|
Post-randomization Period (Week 12-36)
STARTED
|
27
|
26
|
|
Post-randomization Period (Week 12-36)
COMPLETED
|
26
|
26
|
|
Post-randomization Period (Week 12-36)
NOT COMPLETED
|
1
|
0
|
|
Extension Post Random. (Week 36-60)
STARTED
|
26
|
26
|
|
Extension Post Random. (Week 36-60)
COMPLETED
|
19
|
23
|
|
Extension Post Random. (Week 36-60)
NOT COMPLETED
|
7
|
3
|
|
All on TETA 4HCl, From wk 60 Till 108max
STARTED
|
19
|
23
|
|
All on TETA 4HCl, From wk 60 Till 108max
COMPLETED
|
19
|
21
|
|
All on TETA 4HCl, From wk 60 Till 108max
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Penicillamine
Male and female clinically stable Wilson Disease patients, aged ≥18 and ≤75, receiving penicillamine treatment for at least 1 year, stable dose for at least 4 months prior to enrolment. Patients continued on their current penicillamine therapy from week 1 till 12, the baseline period. When confirmed stable, patients were randomized to continue penicillamine (control) treatment for the 24 weeks post-randomization phase (week 12-36). Patients completing the 24-weeks post-randomization phase, were offered to enter a 24 week extension period on their allocated (control) Penicillamine. At the end of the extension period (study end), all patients were offered continuing involvement by switching to TETA 4HCl.
|
TETA 4HCl
Male and female clinically stable Wilson Disease patients, aged ≥18 and ≤75, receiving penicillamine treatment for at least 1 year, stable dose for at least 4 months prior to enrolment. Patients continued on their current penicillamine therapy from week 1 till 12, the baseline period. When confirmed stable, patients were randomized to open label TETA 4HCl (intervention) treatment for the 24 weeks post-randomization phase (week 12-36). Patients completing the 24-weeks post-randomization phase, were offered to enter a 24 week extension period on their allocated (intervention) TETA 4HCl. At the end of the extension period (study end), all patients were offered continuing involvement by switching to or continuing TETA 4HCl.
|
|---|---|---|
|
Penicillamine Baseline Period (Day1-W12)
Baseline run-in failure
|
24
|
0
|
|
Post-randomization Period (Week 12-36)
Withdrawal by Subject
|
1
|
0
|
|
Extension Post Random. (Week 36-60)
Adverse Event
|
1
|
1
|
|
Extension Post Random. (Week 36-60)
Withdrawal by Subject
|
3
|
1
|
|
Extension Post Random. (Week 36-60)
Not further documented
|
3
|
1
|
|
All on TETA 4HCl, From wk 60 Till 108max
Death
|
0
|
1
|
|
All on TETA 4HCl, From wk 60 Till 108max
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease
Baseline characteristics by cohort
| Measure |
Penicillamine Arm
n=27 Participants
Comparator: Penicillamine
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
TETA 4HCL Arm
n=26 Participants
Active Treatment
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 13.43 • n=39 Participants
|
42.0 years
STANDARD_DEVIATION 15.63 • n=41 Participants
|
43.6 years
STANDARD_DEVIATION 14.49 • n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
Brazil
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Region of Enrollment
Denmark
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
Poland
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Region of Enrollment
Germany
|
8 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Week 36Population: ITT
The primary outcome of efficacy was serum NCC by speciation assay (μg/L), with comparative analysis of mean difference between the two groups 24 weeks after randomization. The non-inferiority margin was set at -50 μg/L.
Outcome measures
| Measure |
Penicillamine Arm
n=25 Participants
Comparator: Penicillamine
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
TETA 4HCL Arm
n=26 Participants
Active Treatment
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
|---|---|---|
|
Serum NCC Concentration
|
46.5 µg/L
Standard Error 5.69
|
58.7 µg/L
Standard Error 5.54
|
SECONDARY outcome
Timeframe: Week 3624-hour urinary copper excretion (μg/ 24 hr) from urine collected by the patient over a 24-hour period.
Outcome measures
| Measure |
Penicillamine Arm
n=26 Participants
Comparator: Penicillamine
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
TETA 4HCL Arm
n=27 Participants
Active Treatment
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
|---|---|---|
|
24-hour Urinary Copper Excretion (UCE)
|
274.5 μg/24 hours
Standard Error 45.59
|
510.8 μg/24 hours
Standard Error 47.77
|
SECONDARY outcome
Timeframe: Week 36The clinician will rate the change in the patient's Wilson's disease relative to the prior study clinic visit using a 7-point scale to a specific statement: 'Please rate the change in the overall severity of the patients Wilson's disease compared to the previous study clinic visit". Available options were (1) very much improved; (2) much improved; (3) minimally improved; (4) no change; (5) minimally worse; (6), much worse; or (7) very much worse.
Outcome measures
| Measure |
Penicillamine Arm
n=21 Participants
Comparator: Penicillamine
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
TETA 4HCL Arm
n=22 Participants
Active Treatment
TETA 4HCL: TETA 4HCL
Penicillamine: Penicillamine
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC) Rating Scale
|
4.1 score on a scale
Standard Error 0.10
|
3.9 score on a scale
Standard Error 0.05
|
Adverse Events
D1-W12 Penicillamine Arm
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
D1-W12 TETA 4HCl Arm
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
W12-W36 Penicllamine Arm
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
W12-W36 TETA4HCl Arm
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
W36-60 Pencillamine Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
W36-60 TETA4HCl Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
W60-108 Pencillamine Arm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
W60-108 TETA4HCl Arm
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
D1-W12 Penicillamine Arm
n=27 participants at risk
Penicillamine Baseline Period from Day 1 until randomization at W12
In this period all patients received Penicillamine
|
D1-W12 TETA 4HCl Arm
n=26 participants at risk
Penicillamine Baseline Period from Day 1 until randomization at W12
In this period all patients received Penicillamine
|
W12-W36 Penicllamine Arm
n=27 participants at risk
Post randomization phase, W12 until W36
In this period all patients received their allocated treatement, i.e., Penicillamine
|
W12-W36 TETA4HCl Arm
n=26 participants at risk
Post randomization phase, W12 until W36
In this period all patients received their allocated treatement, i.e., TETA4HCl
|
W36-60 Pencillamine Arm
n=26 participants at risk
Extension phase, W36 until W60
In this period all patients received their allocated treatement, i.e., Penicillamine
|
W36-60 TETA4HCl Arm
n=26 participants at risk
Extension phase, W36 until W60
In this period all patients received their allocated treatement, i.e., TETA4HCl
|
W60-108 Pencillamine Arm
n=19 participants at risk
Extension phase, W60 until \<W108
In this period all patients received TETA4HCL
|
W60-108 TETA4HCl Arm
n=23 participants at risk
Extension phase, W60 until \<W108
In this period all patients received TETA4HCL
|
|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
4.3%
1/23 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
4.3%
1/23 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
4.3%
1/23 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Infections and infestations
Cystitis
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
Other adverse events
| Measure |
D1-W12 Penicillamine Arm
n=27 participants at risk
Penicillamine Baseline Period from Day 1 until randomization at W12
In this period all patients received Penicillamine
|
D1-W12 TETA 4HCl Arm
n=26 participants at risk
Penicillamine Baseline Period from Day 1 until randomization at W12
In this period all patients received Penicillamine
|
W12-W36 Penicllamine Arm
n=27 participants at risk
Post randomization phase, W12 until W36
In this period all patients received their allocated treatement, i.e., Penicillamine
|
W12-W36 TETA4HCl Arm
n=26 participants at risk
Post randomization phase, W12 until W36
In this period all patients received their allocated treatement, i.e., TETA4HCl
|
W36-60 Pencillamine Arm
n=26 participants at risk
Extension phase, W36 until W60
In this period all patients received their allocated treatement, i.e., Penicillamine
|
W36-60 TETA4HCl Arm
n=26 participants at risk
Extension phase, W36 until W60
In this period all patients received their allocated treatement, i.e., TETA4HCl
|
W60-108 Pencillamine Arm
n=19 participants at risk
Extension phase, W60 until \<W108
In this period all patients received TETA4HCL
|
W60-108 TETA4HCl Arm
n=23 participants at risk
Extension phase, W60 until \<W108
In this period all patients received TETA4HCL
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 12 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
10.5%
2/19 • Number of events 4 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 3 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
5.3%
1/19 • Number of events 3 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
4.3%
1/23 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
5.3%
1/19 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
4.3%
1/23 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Gastritis
|
7.4%
2/27 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
General disorders
Pyrexia
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.4%
2/27 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
5.3%
1/19 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Infections and infestations
Influenza
|
7.4%
2/27 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
3/27 • Number of events 3 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Infections and infestations
Sinusitis
|
7.4%
2/27 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
2/27 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
5.3%
1/19 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
3/27 • Number of events 3 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
11.1%
3/27 • Number of events 3 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
4.3%
1/23 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
8.7%
2/23 • Number of events 3 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.4%
2/27 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 4 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 4 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
18.5%
5/27 • Number of events 8 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 4 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
5.3%
1/19 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
4.3%
1/23 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/27 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.8%
1/26 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
3.7%
1/27 • Number of events 1 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
7.7%
2/26 • Number of events 2 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/26 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/19 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
0.00%
0/23 • From Day 1 up to Week 108 / End of Treatment
Displayed (serious) adverse events were collected on randomized patients only. Note that treatment changed from one period to the next, depending on the period and the randomly assigned treatment arm. Patients randomized to the penicillamine arm received resp. Penicillamine, Penicillamine, Penicillamine and TETA 4HCl, from period 1 to 4. Whereas patients randomized to the TETA 4HCl arm received resp. Penicillamine, TETA 4HCl, TETA 4HCl and TETA 4HCl from period 1 to 4.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place