Trial Outcomes & Findings for QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer (NCT NCT00630552)
NCT ID: NCT00630552
Last Updated: 2024-10-17
Results Overview
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
138 participants
Primary outcome timeframe
28 days
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
41
|
42
|
42
|
|
Overall Study
COMPLETED
|
1
|
0
|
4
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
37
|
34
|
39
|
Reasons for withdrawal
| Measure |
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
5
|
4
|
2
|
|
Overall Study
Disease progression
|
5
|
6
|
27
|
22
|
31
|
|
Overall Study
Never received IP
|
0
|
0
|
0
|
2
|
2
|
|
Overall Study
Ineligibility determined
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
4
|
2
|
0
|
Baseline Characteristics
Phase 1b and Phase 2 were not analyzed together.
Baseline characteristics by cohort
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655
n=41 Participants
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 479
n=42 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=42 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Phase 1b
|
67.2 years
STANDARD_DEVIATION 10.7 • n=6 Participants • Phase 1b and Phase 2 were not analyzed together.
|
63.7 years
STANDARD_DEVIATION 15.1 • n=7 Participants • Phase 1b and Phase 2 were not analyzed together.
|
—
|
—
|
—
|
65.3 years
STANDARD_DEVIATION 12.8 • n=13 Participants • Phase 1b and Phase 2 were not analyzed together.
|
|
Age, Continuous
Phase 2
|
—
|
—
|
62.3 years
STANDARD_DEVIATION 9.3 • n=41 Participants • Phase 1b and Phase 2 were not analyzed together.
|
62.1 years
STANDARD_DEVIATION 11.5 • n=42 Participants • Phase 1b and Phase 2 were not analyzed together.
|
62.6 years
STANDARD_DEVIATION 9.1 • n=42 Participants • Phase 1b and Phase 2 were not analyzed together.
|
62.3 years
STANDARD_DEVIATION 10.0 • n=125 Participants • Phase 1b and Phase 2 were not analyzed together.
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=41 Participants
|
17 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
58 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
24 Participants
n=41 Participants
|
25 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
80 Participants
n=138 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=138 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
32 Participants
n=41 Participants
|
35 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
116 Participants
n=138 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=41 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
11 Participants
n=138 Participants
|
|
Metastatic pancreatic cancer
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
41 Participants
n=41 Participants
|
42 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
138 Participants
n=138 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The DLT analysis set consisted of subjects in the phase 1b portion of the study only, who experienced at least 1 DLT in the first 28 days of treatment or received 2 doses of AMG 655, 3 infusions of gemcitabine in a 28 day cycle at doses not less than 750 mg/m2 and were followed for at least 28 days (with or without DLTs).
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Full analysis (The full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment.)
The proportion of subjects alive at 6 months
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=41 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=42 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=42 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Six Month Overall Survival Rate (Phase 2 Portion Only)
|
59.2 percentage of participants
Interval 42.3 to 72.7
|
56.6 percentage of participants
Interval 40.8 to 69.7
|
49.5 percentage of participants
Interval 33.4 to 63.7
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment through up to 36 monthsPopulation: The Safety Analysis Set for Phase 1b (the safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received), and the Full Analysis for Phase 2 (the full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment).
Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=38 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
n=39 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=40 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Objective Response Rate
|
16.67 percentage of responders
Interval 0.42 to 64.12
|
14.29 percentage of responders
Interval 0.36 to 57.87
|
2.63 percentage of responders
Interval 0.07 to 13.81
|
10.26 percentage of responders
Interval 2.87 to 24.22
|
2.50 percentage of responders
Interval 0.06 to 13.16
|
SECONDARY outcome
Timeframe: From start of study treatment through up to 36 monthsPopulation: The Safety Analysis Set for Phase 1b (the safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received), and the Full Analysis for Phase 2 (the full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment)
PFS was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to the first observation of disease progression per investigator review (as classified by modified RECIST or clinical progression, whichever occurred first) or death due to any cause, or censoring. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=41 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
n=42 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=42 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
5.4 Months
Interval 5.3 to 5.6
|
3.5 Months
Interval 1.8 to 13.4
|
3.9 Months
Interval 3.4 to 5.4
|
5.1 Months
Interval 3.2 to 6.0
|
2.1 Months
Interval 1.9 to 3.3
|
SECONDARY outcome
Timeframe: From start of study treatment through up to 36 monthsPopulation: The Safety Analysis Set for Phase 1b (the safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received), and the Full Analysis for Phase 2 (the full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment)
Overall survival was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to death for any cause.
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=41 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
n=42 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=42 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Overall Survival
|
9.0 Months
Interval 5.6 to 17.0
|
8.9 Months
Interval 6.9 to 18.5
|
7.5 Months
Interval 4.8 to 10.0
|
8.7 Months
Interval 5.3 to 12.2
|
5.9 Months
Interval 4.1 to 9.7
|
SECONDARY outcome
Timeframe: From start of study treatment through up to 44 weeksPopulation: The safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received.
Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=41 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
n=40 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=40 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Number of Subjects With an Adverse Event
|
6 Participants
|
7 Participants
|
41 Participants
|
39 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment through up to 48 weeksPopulation: The pharmacokinetic analysis set consisted of all subjects who underwent blood sampling for pharmacokinetic evaluation during the study. Cmax for AMG 655 was not calculated for the Phase 2 AMG 479 group because they did not receive AMG 655. The CMAX for AMG479 was not calculated for Phase 1b groups or the Phase 2 AMG 655 groups because they did not receive AMG 479. CMAX of gemcitabine for day 1 and day 8 were only performed in Phase 1b per protocol.
PK parameter of Cmax for AMG 655 (phase 1b and phase 2 portions) - pg 266, ganitumab (phase 2 portion only) - pg 270 , and gemcitabine (phase 1b portion only - pg 272) PK parameters
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=5 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=11 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
n=13 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
Cmax for AMG 655
|
55.3 μg/mL
Standard Deviation 11.3
|
198 μg/mL
Standard Deviation 32.5
|
198 μg/mL
Standard Deviation 52.7
|
—
|
—
|
|
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
Cmax for AMG 479
|
—
|
—
|
—
|
179 μg/mL
Standard Deviation 55.2
|
—
|
|
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
Cmax for gemcitabine - Day 1
|
15.7 μg/mL
Standard Deviation 7.79
|
14.8 μg/mL
Standard Deviation 7.84
|
—
|
—
|
—
|
|
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
Cmax for gemcitabine - Day 8
|
10.5 μg/mL
Standard Deviation 5.90
|
11.2 μg/mL
Standard Deviation 5.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment through up to 40 weeksPopulation: The safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received.
Average Dose intensity of gemcitabine when combined with AMG 655, placebo or AMG 479
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=41 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=40 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=40 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Dose Intensity of Gemcitabine (Phase 2 Portion Only)
|
861.40 mg/m^2 /infusion
Standard Deviation 119.45
|
906.66 mg/m^2 /infusion
Standard Deviation 115.76
|
936.29 mg/m^2 /infusion
Standard Deviation 79.58
|
—
|
—
|
SECONDARY outcome
Timeframe: From objective response through up to 36 monthsPopulation: Only subjects with a CR or PR were analyzed. Duration of response was only measured for Phase 2.
Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=1 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
n=4 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=1 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Duration of Response
|
—
|
—
|
301 Days
Interval 301.0 to 301.0
|
253 Days
Interval 60.0 to 472.0
|
116 Days
Interval 116.0 to 116.0
|
SECONDARY outcome
Timeframe: From start of treatment up to 40 weeksThe incidence of antibody formation of anti-AMG 655 (phase 1b and phase 2 portions) or anti- ganitumab (phase 2 portion only)
Outcome measures
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 Participants
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655-placebo
n=41 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
Phase 2 AMG 479
n=42 Participants
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=42 Participants
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Incidence of Antibody Formation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Phase 1b AMG 655 3mg/kg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase 1b AMG 655 10mg/kg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Phase 2 AMG 655
Serious events: 23 serious events
Other events: 41 other events
Deaths: 32 deaths
Phase 2 AMG 479
Serious events: 21 serious events
Other events: 39 other events
Deaths: 28 deaths
Phase 2 AMG 655-placebo
Serious events: 20 serious events
Other events: 40 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 participants at risk
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 participants at risk
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655
n=41 participants at risk
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 479
n=40 participants at risk
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=40 participants at risk
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Infusion Related Reaction
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Bilateral Cellulitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Nephrolithiasis
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Deep Vein Thrombosis
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Optic Ischaemic Neuropathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Death
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Disease Progression
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Generalised Oedema
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Stent Occlusion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Lipase Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Primary Tumor
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Embolic Stroke
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
Other adverse events
| Measure |
Phase 1b AMG 655 3mg/kg
n=6 participants at risk
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 1b AMG 655 10mg/kg
n=7 participants at risk
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 655
n=41 participants at risk
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
Phase 2 AMG 479
n=40 participants at risk
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Phase 2 AMG 655-placebo
n=40 participants at risk
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
|
|---|---|---|---|---|---|
|
General disorders
Infusion Site Mass
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
42.9%
3/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
29.3%
12/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
22.5%
9/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
35.0%
14/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
3/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
31.7%
13/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
25.0%
10/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
22.5%
9/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
83.3%
5/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
42.9%
3/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
43.9%
18/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
35.0%
14/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
35.0%
14/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Sinus Bradycardia
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Dry Eye
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
2/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
71.4%
5/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
19.5%
8/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
27.5%
11/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
57.1%
4/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
39.0%
16/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
45.0%
18/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
45.0%
18/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
26.8%
11/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
20.0%
8/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
71.4%
5/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
34.1%
14/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
55.0%
22/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
62.5%
25/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
57.1%
4/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
24.4%
10/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
35.0%
14/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
22.5%
9/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Catheter Site Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Chest Pain
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Chills
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.2%
5/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
20.0%
8/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Early Satiety
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Fatigue
|
83.3%
5/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
100.0%
7/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
63.4%
26/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
47.5%
19/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
55.0%
22/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Infusion Related Reaction
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Infusion Site Pain
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Non-Cardiac Chest Pain
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Oedema Peripheral
|
33.3%
2/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
34.1%
14/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
27.5%
11/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
25.0%
10/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
17.5%
7/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Pyrexia
|
50.0%
3/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
34.1%
14/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
20.0%
8/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
37.5%
15/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Ear Infection
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Skeletal Injury
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Stent Occlusion
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Lipase Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Neutrophil Count Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Waist Circumference Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Weight Decreased
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Weight Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
33.3%
2/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
42.9%
3/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
19.5%
8/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
30.0%
12/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
32.5%
13/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
25.0%
10/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Bilateral Cellulitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.6%
6/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Memory Impairment
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
17.1%
7/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Blunted Affect
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.2%
5/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
20.0%
8/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Nephrolithiasis
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Renal Failure
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Urinary Hesitation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Reproductive system and breast disorders
Breast Pain
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
42.9%
3/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
22.0%
9/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
27.5%
11/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
33.3%
2/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.2%
5/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
17.5%
7/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Deep Vein Thrombosis
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.2%
5/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Haematoma
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
28.6%
2/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.3%
1/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
42.9%
3/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
14.6%
6/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Ocular Icterus
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Optic Ischaemic Neuropathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Gastrointestinal Sounds Abnormal
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Pancreatic Enzyme Abnormality
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Pancreatic Insufficiency
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Sensitivity Of Teeth
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Tooth Disorder
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Catheter Site Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Chest Discomfort
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Death
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Disease Progression
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Gait Disturbance
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Generalised Oedema
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Hernia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Infusion Site Hypersensitivity
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Localised Oedema
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Malaise
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Oedema
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Temperature Intolerance
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Biliary Tract Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Infected Cyst
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Open Wound
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Alanine Aminotransferase
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.2%
5/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
17.5%
7/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Aspartate Aminotransferase
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.2%
5/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
20.0%
8/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Albumin Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Alkaline Phosphatase
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Amylase
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Amylase Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Bilirubin
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Calcium Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Cholesterol
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Creatinine
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Magnesium Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Blood Uric Acid Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Glucose Urine Present
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Haemoglobin
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Heart Rate Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Lipase
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Neutrophil Count
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
17.1%
7/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.5%
5/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
General disorders
Primary Tumor
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid Neoplasm
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
9.8%
4/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
15.0%
6/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
12.2%
5/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Embolic Stroke
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Choluria
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Renal and urinary disorders
Urge Incontinence
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.3%
3/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
10.0%
4/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Upper Airway Secretion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
7.5%
3/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
4.9%
2/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Capillary Leak Syndrome
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Orthostatic Hypertension
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
5.0%
2/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Phlebitis Superficial
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.5%
1/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/6 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/7 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
2.4%
1/41 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
0.00%
0/40 • Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place